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Alinity c

Global Field Service Training Program

Participant Guide

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Table of Contents
Alinity c

Course Introduction ....................................................................................Intro-1

1 Instrument Overview and Basic Operations .................................................. 1-1

2 Power Distribution ............................................................................................. 2-1

3 Electronic Circuitry ........................................................................................... 3-1

4 Robotics ............................................................................................................ 4-1

5 Fluidics .............................................................................................................. 5-1

6 Optics ................................................................................................................ 6-1

7 Temperature Control........................................................................................ 7-1

8 Installation and Software ................................................................................. 8-1

9 Lab Practical and Final Exam ......................................................................... 9-1

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Revision History
Revision History

Document Control
Revision Date Content or Pages Revised, Added, or Deleted
Number

80001189-101 Dec, 2017

Any product information in training materials should be used in conjunction with the latest
version of the Operations Manual, Operations Manual addendum, or Product Information
Letter. If discrepancies in information exist within training materials or any other materials,
the latest version of the Operations Manual, Operations Manual addendum, or Product
Information Letter takes precedence.

All samples (printouts, graphics, displays or screens, etc.) are for information and illustration
purposes only and shall not be used for clinical or maintenance evaluations. Data shown in
sample printouts and screens do not reflect actual patient names or test results.

Each person assumes full responsibility and all risks arising from use of the Information. The
Information is presented “AS IS” and may include technical inaccuracies or typographical
errors. Abbott Laboratories reserves the right to make additions, deletions, or modifications to
the Information at any time without any prior notification.

All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott
Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade
dress, or product name may be made without the prior written authorization of Abbott
Laboratories, except to identify the product or services of Abbott Laboratories. All other
trademarks, brands, product names, and trade names are the property of their respective
companies. All rights reserved. Except as permitted above, no license or right, expressed or
implied, is granted to any person under any patent, trademark, or other proprietary right of
Abbott Laboratories.

This guide was developed and produced by Global Service Training, Dallas, TX.

© 2017, Abbott Laboratories, Abbott Park, Illinois.

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Objectives Course Overview

Course Overview

Estimated Time: 1.5 Hour

Objectives
 Review training guide notations, class goals, and required pre-
learning activities

 Discuss key safety and compliance service information

 Define class expectations

 Reinforce AST tools and service cadence concepts used in this


training

Module Topics
 Introduction

 Training Overview

 Goals

 Prerequisite Activities

 Materials

 Safety and Hazards

 How To Use This Guide

 Service Cadence
 Achieving Service Excellence
 Effective Troubleshooting
 KM Service Documents

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Course Overview Module Topics

Training Overview
Time: 30 mins

Instrument Description
The Alinity ci-series provides full integration of clinical chemistry and
immunoassay analysis. The Alinity ci-series includes a clinical chemistry
module and an immunoassay module, each performing all sample
processing activities, and a system control module to provide a single
common interface. Each system can be customized by combining
one or more sample processing modules, in multiple configurations,
with a system control module to form a single workstation.

The Alinity c processing module is a fully automated chemistry analyzer


allowing random and continuous access, as well as priority and
automated retest processing using photometric and potentiometric
detection technology. The Alinity c processing module uses
photometric detection technology to measure sample absorbance for
the quantification of analyte concentration and uses potentiometric
detection technology to measure the electrical potential in a
sample. In addition, the Alinity c processing module uses an
integrated chip technology (ICT) module to measure potentiometric
assays(electrolytes). Mutlimodules usually consist of 2 modules are
usually a ci-series configuration.

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Module Topics Course Overview

Goals
Upon completion of this training program, you will be able to:

 Use online resources to locate Alinity c product information and


procedures

 Describe the role each major functional area plays in the Alinity c
clinical chemistry process

 Perform basic operations, including daily maintenance, basic run,


and calibrations

 Use resources to interpret troubleshooting data, isolate root causes


of failure, and verify normal operation

 Perform key maintenance, diagnostic, component removal and


replacement procedures

 Perform the procedures associated with Prognostic Health


Monitoring (PHM), Preventive Maintenance (PM) and instrument
installation

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Course Overview Module Topics

Prerequisite Activities
In preparation for class, you must complete pre-training prior to
the class. This material is mandatory. It is designed to provide a
baseline level of knowledge and will immediately begin building
your understanding of the Alinity c. The material will not be covered
in class. It ensures all learners are at the same level of preparedness
for classroom activities and supports maximum hands-on instrument
troubleshooting during the training.

Prerequisite activities that must be completed are:

 Alinity c Overview CBT

 Alinity System Software CBT

 Alinity ci-series SCM, Computers & Software Overview

 Immunoassay Background CBT

 AbbottLink Customer Training CBT

 Service Tools Overview

 AST Tools Overview CBT

 Predictive/Preventive Maintenance (PdM) Overview

 Obtain AbbottLink ID and password to access AbbottLink

 Apply for Abbott Medical Password Generator (AMDPG)


application access

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Module Topics Course Overview

Materials
The information for the Alinity c Field Service Training will be presented
by instructors using the following materials:
 Alinity c Global Field Service Training Program
 MyGSS or Alinity c Service Documentation
 Alinity ci-series Operations Manual (Online Help)
 Alinity immunoassay and Clinical Chemistry System Operations
Manual
 Alinity ci-series Assay-specific Package Inserts
 Knowledge Management troubleshooting database
 Remote diagnostics tools: AbbottLink and LOG-ICAL
 Ticket Code Tools (TCT) Database
 Technical Service Bulletins (TSB)
 Instrument Service Advisories (ISA)

 Note: All example printouts, graphics, displays, screens, etc. are


for information and illustration purposes only. Actual printouts,
graphics, displays, screens, etc. may vary depending on software
revision, hardware revision, and instrument configuration.

The Service and Support Manual, System Operations Manual, assay-


specific package inserts, TSBs, and ISAs can be accessed through
the Abbott Global Service and Support (MyGSS) intranet site unless
otherwise noted.

Service personnel should keep their laptop, iPad, and programs


updated to contain the most current revision of materials.

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Course Overview Module Topics

How To Use This Guide

Typography

Black Text Black text will appear in both Facilitator Guide and Participant Guide
Citation Book titles and other references will be green in color

Activity: Name of Activity

Activity: Activities are provided throughout the guide to give participants an opportunity to
practice the concepts and techniques discussed.

 Note: The facilitator and class participants should review activity


steps together before commencing individual actions.

Special Tables for Notes and References

 Note: Denotes operator or service information.

Caution: Denotes a condition or activities that could result in minor


injury or interfere with proper functioning of the system.

WARNING: Denotes a physical, mechanical, or procedural condition


that could result in moderate to serious personal injury.

 Reference: This notation provides references to published materials


or online manuals.

 Video: This notation calls attention to available animations or


instructional videos for a given topic.

 Abbott: Calls attention to activity using resources only available to


Abbott personnel.

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Module Topics Course Overview

Safety and Hazards


The Alinity c has been designed for optimum operator safety.
However, this does not reduce the importance of safety awareness
where hazards exist. This section describes the types and locations of
potential hazards that could cause physical harm or damage to the
laboratory environment or where failure to follow instructions may result
in instrument failure or generation of erroneous patient results.

WARNING: You must follow approved service documents when servicing


ADD products to ensure the product is performing within
specifications and meets regulatory approval. Failure to
maintain our product per approved documents:
 May result in the product being considered adulterated, or
unlicensed, and violate regulatory approvals
 May increase the risk to the user/ operator
 May compromise the results generated and lead to adverse
patient management

 Note: Refer to Escalation Procedure in DMS DFP19.001 for Escalation


Contact Support (phone & email) details

Warnings are inserted throughout Alinity c Service Documentation to


alert Field Service Representatives (FSRs) to potential hazards.

It is important to wear gloves, lab coats, and protective eye wear


when handling human sourced material or contaminated instrument
components.

If the possibility of pressurized liquid exists, or if significant force is


needed to perform operations where liquid may be present, full-face
protection is recommended.

 Reference: See Alinity c Service Documentation > 1. Alinity c


General > Document Organization, Legal, Safety and Hazards
and the information below for safety hazard information prior to
beginning this training course.

 Biological Hazards  Mechanical Hazards


 Chemical Hazards  Safety Symbols & Classification
 Electrical Hazards  Physical Hazards
 Electrostatic Discharge (ESD)  Safety Icons and Hazard Symbols
 Hazard Signal Words  Waste Handling and Disposal

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Course Overview Service Cadence

Service Cadence
Time: 60 min Daily Service Cadence is integrated with course technical learning.
The following topics are necessary as part of the Service Cadence
expectations for service product support. A brief overview of how it is
integral to service and support are highlighted in this section.

 Reference: See MyGSS Service Cadence Portal; Resource


Documents and Rules for Engagement folders for additional
information.

Abbott Personnel can access references to documents supporting


information related to Key Performance Indicators (KPI) in the Service
Cadence portal area of MyGSS. This area contains the following
reference documents:

 HCP and HCI Cadence training


 Managing high cost parts and high cost instrument accounts

 ASE Proactive Customer Care

 AST Introduction

 Additional LMS course for


- ASE Proactive Customer Care
- Effective Troubleshooting
- AbbottLink & Logs
- AST Tools
- Service Cadence Tools (additional resources)

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Service Cadence Course Overview

Achieving Service Excellence


Daily Service Cadence is integrated with course technical learning.
The chart below outlines the Abbott proactive customer interaction
cycle.

 Reference: See MyGSS Service Cadence Resource Documents and


Rules of Engagement folders portal for additional information.
Abbott Personnel can access references to documents supporting
information related to Key Performance Indicators (KPI) in the
Service Cadence portal area of MyGSS. This area contains
reference documents for managing High Cost Parts (HCP) and
High Cost Instrument (HCI) accounts.

The ASE model uses the following with the AST Tools to prevent
instrument failures, lab down-time and to proactively support the
customer.

 Alinity uses prognostics and Prognostic Health Management


(PHM) to help monitor the system performance. Prognostic Health
Notification (PHN) alerts are sent to service when monitored
component indicators show a trend intervention is needed to
prevent a reactive service ticket or a customer inconvenience.

 Prognostics focuses on predicting the time at which a system or a


component will no longer perform its intended function.

 Prognostic Health Management (PHM) is a family of notifications,


algorithms, and systems which all work together to proactively
monitor instruments for conditions which could cause a service
ticket or inconvenience for our customers.

 Prognostic Health Notification (PHN): alert created predicting a


probable instrument failure to help prevent instrument down time
as part of the PHM process.

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Course Overview Service Cadence

 Achieving Service Excellence (ASE): Proactive Customer Care Interaction Cycle

Review the customer interaction cycle below.

PRE-VISIT ACTIVITIES
Be Ready - Review
 ONeview: Instrument Health Notification/POM
Alert; related tickets
 Key customer metrics [note red customer KPIs
for all calls]
 Knowledge Management check, ensure
accuracy
Receiving
 Initiate contact and plan timely intervention
(Planned Service)
 Assure customer of proactive approach with
PHM and ALWAYS ON

DURING VISIT
Understanding:
 Demonstrate Active Sense Technology –
provide visual
 Share Instrument Health Notification / POM Alert or and PHM related information
 Provide more detailed visual
Helping:
 Perform Proactive service call or PHM ticket
 Utilize Knowledge Management
 Utilize Chat or FaceTime with SME if needed
 Perform Total Call (address reasons for red KPIs in ONeview)
Keeping:
 Conversation with the Customer: Account health
 Ensure AbbottLink connectivity
 Discuss proactive actions for red customer KPIs (high CPY in ONeview)
 Provide Service Report
Follow Up:
 Follow up with customer next day
 Utilize ASE Skills
 Continue to monitor instrument to confirm resolution

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Service Cadence Course Overview

Effective Troubleshooting
Effective troubleshooting and problem resolution requires four logical
STEPs.

1. STOP: Identify the problem

2. THINK: Gather information/data/clues


 Look for comparison (what is working versus what is not working)
 Categorize failure
 Analyzer: Refer to instrument hardware and software
problems which can interfere or influence generation of
correct results (pFORT):
 Power
 Fluidics
 Optics
 Robotics
 Temperature
 Operator: Refer to human-associated interventions which
can interfere with correct result generation such as:
 Improper sample type for analysis
 Improper sample loading or handling
 Bubbles present in reagent or sample
 Reagent: Refer to problems with Reagent, Calibrators and/or
Controls such as:
 Improperly stored products
 Expired reagent, calibrators or controls
 Control ranges established incorrectly
 Environment: Refer to laboratory and surrounding conditions
that can influence the result. These may include:
 Electrical and physical specifications (spatial layout)
 Computer and user interface specifications

3. EVALUATE: identify potential causes (including subcomponents and


high cost part (HCP) evaluation
 Verify problem
 Check causes against data

4. PROCEED: Resolution/corrective action (which includes utilizing the


most cost effective solution) to isolate and correct root cause of
failure; perform repair
 Verify problem resolution
 Complete all checklists and verifications

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Course Overview Service Cadence

Activity: Global Service Reports (GSR) Activity

 Abbott: This tools activity is for Abbott personnel only.

Estimated Time: 20 minutes

Purpose: Gain competency using the GSR Active Sense Technology


(AST) Tools and initiate awareness of high cost parts and goal

Actions: Open the GSR database from MyGSS AST Tool table, access
the GSR Reports and complete each activity below:

1. Locate the FASTR (Failure Analysis Statistical Tactical Resolution)


report, select the following options to filter the data, and record the
top 10 reasons for a service request.

Top Area Options Left Side Options


 Instrument: Alinity c  Experience Codes
 Date Range for Closed tickets: Scope: 4 character
recent 6 months code
 Top Codes: 20

2. Select SUBMIT from the top left to filter data.

3. Write the first 10 in the table below.

1) 6)

2) 7)

3) 8)

4) 9)

5) 10)

4. Locate the Parts Viewer report, select the following options to filter
the data, and record the top 10 reasons for a service request.

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Service Cadence Course Overview

Top Area Options Left Side Options


 Instrument: Alinity c  Views: Parts Advanced
 Date Range for Closed  Filters:
tickets: recent 6 months  Ticket Type: Complaint &
Service Demand
 Action Taken: N110
(Replaced) & N120 (Replaced
First Use Failure)
 Limit to Likely Cause
 Parts Ticket Category: Repair FSV
 Options: Choose top 20 parts
 Sort by: Quantity

5. Select SUBMIT from the top of the screen.

6. Write the top 10 parts replace below.


1) 6)

2) 7)

3) 8)

4) 9)

5) 10)

7. Review the Avg. Unit Cost (standard) column and place a check-
mark next to a part if the cost is >$1000 US global goal to indicate a
high cost part.

Discussion: Instructor will provide assistance to answer questions or


clarify procedure.

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Course Overview Service Cadence

KM Service Documents

 Reference: KM database Alinity c Service Documentation for this


review discussion.

 Alinity c General Data


 Functional systems area summary
 Key diagrams, M & Ds and Alignment / Adjustment procedures
tables

 Troubleshooting:
 Diagrams
 Power Supplies
 Card Cage and Miscellaneous Boards
 LEDs and Test points
 Board silkscreen actual layout

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Service Cadence Course Overview

Activity: Knowledge Management (KM)

Time: 30 mins

Purpose: Become familiar with the information included in the Service


Documentation article in KM.

Actions: Search for the Alinity c Service Documentation and complete


the following:

1. What is the Card cage back plane connector for the ICT Pre Amp
Board?

Answer: ________________________________________________________

2. List the Driver Box Boards

Answer: ________________________________________________________

3. What is the M&D number and description that will tests the Optics
trigger sensor and displays the trigger sensor value.

Answer:

_________________________________________________________________

4. a). What is the R&R number for the Reagent Positioner Assembly?

Answer: ____________________________________________________________

b). List the verification procedure(s) required after removing or


replacing the assembly.

Answer:

___________________________________________________________

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Instrument Overview and Basic Operations

Instrument Overview and


1 Basic Operations

Estimated Time: 7.5 Hours

Objectives

 Identify primary functional areas, major components and


subsystems of the Alinity c

 Identify procedures used during system installation and verification


of service repairs

 Perform procedures to replace consumable system inventory

 Perform basic run operations: specimen, control and calibration


runs

Module Topics

 Instrument Overview
 Instrument Statuses
 RSM Status
 System User Access Levels
 System Inventory
 Required consumables
 Inventory management
 Required Accessories

 Maintenance and Diagnostic Procedures


 Procedure Key
 Backup
 Maintenance and Diagnostic Activity

 Assay Processing
 Detection Technologies
 Assay Processing sequence
 Assay File Installation
 Assay Calibration
 Assay Quality Control

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Instrument Overview and Basic Operations

 Assay Precision
 Assay Processing Activity

 AST Activity

 Instrument Overview and Basic Operations – Summary

 Review – Instrument Overview and Basic Operations

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Instrument Overview and Basic Operations

Instrument Overview
Time: 60 mins Delivery Method: Review functional areas, components and
subsystems. Participants should be in front of the analyzer for this
section.

 Reference: See Alinity ci-series Operations Manual > Section


1: Use or function Alinity c Service Documentation > Instrument
Overview for this discussion.

Topic Reference
Functional This topic was covered in the pre-learning materials.
Areas  System control module (SCM)
 Reagent and sample manager (RSM)
 Processing module (Proactive Procedures)

System The ci-series can be configured as follows:


Configurations  One stand-alone chemistry system.
 A multimodule system that can include a maximum of four chemistry
processing modules.
 An integrated system that can include a maximum of four processing
modules in different combinations of chemistry and immunoassay
processing modules.

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Instrument Overview and Basic Operations

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Instrument Overview and Basic Operations

Instrument Statuses
Time:10 mins Delivery method: class discussion and demonstration in front of
instrument.

Instrument status refers to the operational modes of the ci-series. The


information is displayed on the Home screen.

 Reference: See Alinity ci-series Operations Manual > Section 5:


Operating Instructions > Home screen > Instrument statuses to
describe the following instrument statuses.

Status Description
Offline Indicates when the processing module is not communicating with
the system control module (SCM).
Stopped Indicates when the processing module is turned on and is
communicating with the SCM.
Initializing Indicates a temporary status that occurs when Start or Run on
the Home screen is selected
Warming Indicates when the processing module has completed
initialization but has not reached the required temperature.

 Note: This status is not displayed for the RSM.


Idle Indicates when the processing module has successfully
completed initialization and is ready to accept a run request..
Running Indicates when the processing module has successfully
completed initialization and is ready to process tests.
Processing Indicates when the processing module is actively processing tests

 This status is not displayed for the RSM.


Pausing Indicates when the processing module is not aspirating samples
and is completing assay processing before the module status
transitions to Idle or Stopped.
Maintenance Indicates when a maintenance procedure or a diagnostic
procedure is in process on the processing module.

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Instrument Overview and Basic Operations

RSM Status Indicator LEDs


Time:10 mins

Three status indicators (blue, green, and amber) are located above each reagent and
sample manager (RSM) position to indicate the status of sample processing and when racks
and cartridges can be accessed.

Status Description
Indicators off  No rack or cartridge is inserted in the position.
Green (steady)  The rack or cartridge is inserted but is not in process.
 The rack or cartridge can be accessed
Amber (steady)  The rack or cartridge is in process.
 The rack or cartridge cannot be accessed.
Green (blinking) Processing is completed. The rack or cartridge can be accessed.
Amber (blinking):  Unloading of a cartridge or vial rack is in process.
 The position is reserved and is unavailable to load a rack or
cartridge can be accessed.

 Note: If a test is added or a rerun is scheduled before


the rack is removed from the loading area, the status
indicator for the position changes to amber and the rack
cannot be accessed.
Amber and  A bar code scan error or other error occurred.
green(alternating)  The rack or cartridge can be accessed.
Blue The RSM position is designated as a priority position.

System User Access Levels


Time:10 mins Delivery Method: Review system log in options for the various user
access levels.

 Reference: See Alinity c Service Documentation, Procedures


P-1001 Service Log On/Log Off Procedure.

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Instrument Overview and Basic Operations

User Access Level Description Password or PIN


Configurable ID Required to display operator ID on printouts Customer
and reports configurable
Admin Required to perform: 4-digit PIN
 System configuration Default 8642

 Specific diagnostic procedures


 Approve Maintenance Log
CSC Required to perform procedures not Required access
available to the administrator: to Abbott Medical
 Restore software Device Password
Generator (AMDPG)
 Diagnostic procedures
FSE Required to perform procedures not Require access to
available to the administrator or CSC: Abbott Medical
 Edit configuration settings Device Password
Generator (AMDPG)
 Diagnostic procedures
 Access to Task Manager

 Note: Alinity c FSE log on for


instructions

Caution: User passwords are confidential. You are required to


log off as FSE at the end of service activities to prevent
compliance risks, system errors, and safety issues.

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Instrument Overview and Basic Operations

System Inventory

Required Consumables
Required consumables are replenishable items that are needed for
Time:30 mins
sample processing.

 Reference: See the Alinity ci-series Operations Manual >


Section 1: Use or function > Required consumables; Section 4:
Performance characteristics and Specifications > Specifications
and requirements > Sample specifications and requirements;
and Section 5: Operating Instructions > Reagent inventory
management. Also see Assay specific c assay inserts.

Consumables Description
Assay Reagents  One or more cartridges that contain all the necessary reagent
components for an Alinity ci-series assay.
 One reagent assay kit – contains 1 reagent cartridge bottle
 Two reagent assays kit – contains 2 reagent cartridge bottles
 Cartridges contain a two-dimensional bar code which includes
the following information:
 Reagent identifier
 Reagent serial number
 Number of tests (test size)
 Expiration date
 Onboard stability time

ICT Module  Contains the sodium (Na+ ), potassium (K+ ), chloride (Cl- ), and
reference electrodes.

 ICT module will be discussed further in Fluidics Module

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Instrument Overview and Basic Operations

Consumables Description
Bulk Solutions  Liquid solutions that are provided in large quantities for use
during sample processing.

Solution Description
ICT Reference A mid-concentration standard solution that
Solution (1L bottle) is aspirated and analyzed by the ICT module
before and after each sample. The solution
provides a reference potential that is used in
result calculation.
Alkaline Wash Used by the cuvette washer to clean the
(0.5L bottle) cuvettes after sample analysis.

Acid Wash (0.5L Used by the cuvette washer to clean the


bottle) cuvettes after sample analysis. A dilution of
the Acid Wash solution is used to wash the
probes.

Onboard Solutions  Detergents used during system operation to wash sample


(Smart Wash probes, reagent probes, mixers, and reaction cuvettes. May also
solutions) be used during M&D procedures.
 Onboard solutions include:
 0.5% Acid Wash
 Detergent A
 10% Detergent B
 Solutions are shipped ready to use
 Contain a barcode label and tracked by the system.

 The solutions are used by the Smart Wash feature that


provides an additional wash process(when needed)
for reagent probes, sample probes, and cuvettes to
reduce interference (carryover) between specific assay
combinations.

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Instrument Overview and Basic Operations

Item Description
Sample Cups Topic was covered in pre-training materials.
 1400μL disposable containers that hold
samples for testing.
 Volume graduation marks at 125μL, 500μL,
and 1400μL eliminate the need to pipette
with precision.
 Can be placed in sample tubes with
bar code labels to facilitate positive
identification.

 Reference: Sample cup graphic with volume call outs


from Alinity ci-series Operation Manual > Section 4:
Performance characteristics and Specifications >
Specifications and requirements > Sample specifications
and requirements.

Maintenance Barcoded solutions cartridge used for


Cartridges maintenance procedures. The Alinity c
uses a cartridge for Daily Maintenance with
solutions:
 Water Bath Additive
 Maintenance Solutions
 The reconstituted maintenance solution
is added to the small bottle.


 Reference: See Alinity ci-series Operations Manual > Section 1:
Use or function > Required consumables for important details
regarding storage and use of consumables.

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Instrument Overview and Basic Operations

Inventory Management
Time: 10 mins System inventory is viewed and managed using the following screens:

 Reagents screen: Used to view and manage cartridges and racks


that are loaded in the reagent carousel. On the Reagents screen,
the following functions are available:
 View current and historical (previously loaded) reagent carousel
inventory
 Search for a specif c cartridge or rack
 Access reagent cartridge details
 Unload or disable a reagent cartridge
 Print a reagent report

 See the Alinity ci-series Operations Manual > Section 5: Operating


instructions > Reagent and sample management > Reagent
carousel inventory management

Supplies screen: Used to view and manage onboard consumable


inventory. On the Supplies screen, the operator can view the following
information for the Alinity c processing module:
 Percentage of bulk solutions
 Reset bulk solutions

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-11
Instrument Overview and Basic Operations

Required Accessories
Time: 15 mins Required accessories are parts that are needed for sample processing
on the Alinity c. Required accessories include the following:

Item Description
Racks and Trays  Racks: Used to transport specimens, calibrators, and controls to
the sample pipettor by the RSM
 Vial rack: Bar-coded for identification with the
letter V. Holds six open vials of calibrators or
controls for immediate use. The rack cannot be
stored in the reagent carousel.
 Onboard vial rack: Bar-coded for identification
with the letter U. Holds six vials of calibrators
or controls. The rack is stored in the reagent
carousel. The carousel position will display as
purple in the Reagents screen. Onboard racks
can be assigned by the operator.
 Sample rack: Holds six primary tubes, aliquot
tubes, or sample cups. Any combination of
tubes can be used in the rack.
 Sample Gauge: used to verify the amount in
an aliquot tube exceeds 8mm.
 Trays: Used to hold multiple racks of samples,
calibrators, and controls and to hold reagent
cartridges. Trays of racks and cartridges are loaded on the
reagent and sample manager. Each tray holds a maximum of
five racks or cartridges.

 Reference: See Alinity ci-series Operations Manual >


Section 1: Use or function > Required accessories for this
discussion.

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Maintenance and Diagnostic Procedures

 Note: Basic screen overview was covered in pre-training.

 The Procedures screen displays maintenance and diagnostic


procedures that can be performed.
 The Maintenance tab displays procedures for regularly
scheduled maintenance and as-needed cleaning.
 The Diagnostics tab displays procedures that can be used to
help isolate and identify instrument issues.
 Instrument can be configured to disable sample run if any
scheduled Maintenance is pending completion that is required.

 Note: A software configuration check box is available to prevent a


run initialization when any maintenance is still pending.
Location for check box is found in:
- Configuration/ Computer/ General Settings/ System Information
- Checkbox: “Disable Sample Processing When Maintenance
Overdue “Note: The procedures access will depend on the user
logon access level.

 Reference: See the Alinity ci-series Operations Manual > Section


9: Service, maintenance, and diagnostics > Maintenance and
diagnostics.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-13
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Procedure Key
Time: 15 mins Provides access to the front and rear processing center covers of the
Alinity ci-series processing modules and the RSM by overriding the
interlocks for the processing module and SCM covers.

The procedure key is required to perform maintenance procedures,


diagnostic procedures, and component replacement procedures
when turned horizontally.

Procedure key location for SCM Procedure key location for Alinity c

Procedure Key overrides all the Processing Module, RSM and SCM
covers

 Two identical keys are shipped with the instrument.


 1 set for the SCM
 1 set for the Proactive Procedures

 Procedure keys are shipped insert into the SCM module and can
be move for use to any module.

 All Alinity procedure keys are identical.

 Allows customer and service to perform procedures and specific


M&D tasks

1-14 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Backup
Time: 10 mins
.

System backup is a recommended maintenance procedure for the


Alinity c. System backups provide a means to protect against data loss
in the event of a hard disk failure or software database error. System
Backups can be configured and scheduled to occur automatically.

 Note: Automatic backup is a customer configurable option.

System Backup stores up to three backups (FIFO). System Backup will


create a backup of the following three files:
 Module Calibrations - system calibration files, robo.cal, & ish.cal files
 System Configurations - default host and system parameters
 Module Database - system database file, M&D procedures, assay
files and calibrations, results, module and SCC configuration

Two backup types are available on the Backup/Restore screen:

 Automatic

 Manual

 See Alinity ci-series Operations Manual, Section 2: Installation


Procedures and special requirements.

The following are key points related to the System backup:

 Backups are saved to the hard drive and scheduled to save to an


external USB flash drive

 7 daily automatic backups and 4 weekly automatic backups can


be saved to the hard drive

 Automatic System backups can be scheduled in the System


screen. A USB flash drive MUST remain inserted in the UIC to perform
this feature. Defaults:
 Daily backup default time is 1:00am
 Weekly Backup default is Sunday

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Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

System Management Activities

Activity: Back up and Scheduled Maintenance Activity

Time: 60 mins
Purpose: To familiarize participants with performing a manual
instrument backup.

 Reference: Refer to Alinity ci-series Operation Manual Operations


Manual Section 2: System Configuration, Installation Procedures
and special requirements.

Actions: The participant will perform the following procedures using


on-screen instructions:

1. Perform a manual System Backup


a. Create Backup:
1) On the menu bar, tap System, and then tap Utilities.
2) On the Utilities screen, tap Backup/Restore.
3) On the Backup/Restore screen, tap Create Backup to
save a backup on the hard drive.
4) Type the reason that the manual backup was performed
in Comment box, and then tap Done.
b. Copy backup to a USB flash drive:
1) Insert the USB flash drive.
2) On the menu bar, tap System, and then tap Utilities.
3) On the Utilities screen, tap Backup/Restore.
4) In the Copy Backup flyout, tap the USB flash drive and
folder to which to copy the backup.
5) Tap Done.
6) Remove the USB flash drive.

2. Perform M&D 5501 Daily Maintenance

Discussion: Backup and maintenance procedures are required part


of customer procedures to ensure system health and Abbott goal
support. Check for understanding by observing the activity and
clarifying any key points.

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Assay Processing

Detection Technologies
Time: 10 mins Photometric Technology

Photometric technology is used to determine analyte concentration


by passing a beam of light through a sample and measuring the
amount of light that the sample absorbs. The absorbance of the
solution changes as reagents are added and the reaction progresses.

Measurements occur either when all the reactant is depleted and the
reaction is stable (end-point assays) or when the reactant reaches a
stable rate (rate assays).

Potentiometric Technology

Potentiometric technology is used to measure the electrical potential


in a sample as an indication of electrolyte concentration.

The Alinity c uses the Integrated Chip Technology (ICT) module


to simultaneously measure sodium, potassium, and chloride
concentration. The ICT module uses solid-state, ion-selective
electrodes that are contained in one chip.

 Reference: See Alinity ci-series Operations Manual > Section 3:


Principles of operation > Principles of operation (c-series) for a
description of the these detection methods.

 Note: Additional method details will be reviewed in later sections.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-17
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Assay Processing Sequence


Time:10 mins Delivery Method: Review how samples progress through the assay
processing sequence in class and at the instrument.

 Reference: See Alinity c Service Documentation > System


Overview.

The reaction carousel contains 187 cuvettes in a water bath that is


maintained at 37°C.

During a run, the carousel rotates counterclockwise approximately


1/4 turn or 47 cuvette positions turn every 4.0 seconds (lock step) to
position the cuvettes for:
 Sample and reagent aspiration
 Mixing
 Photometry and ICT Analysis
 Cuvette Washing

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Position(s) Description
1 The sample pipettor dispenses sample into the cuvette at the
starting position.
2 The reaction carousel rotates counterclockwise approximately ¼
turn (47 cuvette positions). The cuvette containing sample is now
at the first reagent dispense position. Reagent pipettor 1 dispenses
reagent 1 in the cuvette.
3 The reaction carousel rotates one cycle (¼ turn) to the first mixing
position where the mixer unit (mixer 1) mixes the sample and
reagent 1.
4 The reaction carousel rotates one cycle to this position at which no
activity takes place.
5 The reaction carousel has completed 4 cycles. Each cycle rotates
the reaction carousel 47 cuvette positions (¼ turn). There are 187
cuvettes in the reaction carousel. After 4 cycles the cuvette is now
one position beyond the original starting position (4x47=188).
6–153 The reaction carousel continues to rotate and the reaction mixture
incubates. The photometer takes absorbance readings every
time the cuvette passes the photometric position. The optics take
absorbance readings every time the cuvette passes the light path
for a total of 38 read times.
154–182 The cuvette washer removes the reaction mixture to waste and
cleans the cuvette with Alkaline Wash, Acid Wash, and DI water.
Then the cuvette washer dispenses DI water into the cuvette for a
water blank measurement to ensure cuvette integrity. Finally, the
cuvette washer aspirates the water and dries the cuvette.
183–188 The clean cuvette waits for new sample dispense.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-19
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Some assay protocols may also use the following locations.

Position(s) Description
5 If onboard dilution is required, the sample pipettor aspirates the
diluted sample and dispenses the sample into the new cuvette that
is currently at position 1.
40 For an ICT sample, the ICT probe aspirates the diluted sample into
the ICT unit.
75 If the reaction requires a second reagent, reagent pipettor 2
dispenses reagent 2 into the cuvette.
76 The mixer 2 mixes the second reagent with the sample and reagent
mixture.

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Assay File Installation and Configuration


Time: 10 mins The operator can install new or revised assay files from the Configure
screen, Assay tab.

The Assay tab also provides for assay configuration tasks, such as:
 Configure assay parameters
 Configure assay panels
 Configure a calibrator set

 Reference: See Alinity ci-series Operations Manual > Section


2: Installation procedures and special requirements > System
configuration > Configuration screen, Assay tab to review settings
that the operator can configure.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-21
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Assay Calibration
Time: 10 mins Calibration is the process used to analyze calibrators of a known
concentration, to record system response values, and to plot
measured values against the known concentration.
 Before performing sample processing, calibrate all assays.
 Assay calibrations require assay-specific calibrators for analysis.
 Acceptable calibration curves are valid when a QC analysis is run
and data are within specifications.

 Note: When samples are ordered the system software calculates


the minimum sample cup volume required for testing.
 Only a printed Orderlist provides the required testing volume for
each sample dilutions and replicates for a specific assay during the
ordering process.

 Reference: See Alinity ci-series Operations Manual > Section 6:


Calibration procedures > Calibration guidelines

Assay calibration frequency options:

 Mandatory or optional

 Reasons for a mandatory calibration include:


 A new reagent lot number
 Documentation accompanying a new version of an existing
assay file states calibration is required
 A new assay file that requires calibration is installed
 The Alinity c is installed (no calibration data exists)
 The Alinity c hard drive is replaced and files were not backed up
 When adding and integrating a stand-alone Alinity i to an
Alinity c processing module

 Note: Refer to service procedures for additional information.

Calibration Data

The Alinity c measures sample photometrically and potentiometric to


report results. Assay calibrations are stored by the system and have
one of the following statuses:

 Active – values are within specifications and the system software


will calculate patient and QC results from this curve
 1 calibration curve is stored per lot number

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

 4 different reagent calibration curve lot numbers are stored at


one time before overwriting information of the oldest stored
curve

 Inactive: previously active curve

 Failed: values fall outside specification

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-23
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Assay Quality Control


Time: 10 mins Assay Quality Control (QC) is the process of monitoring control activity
using control reports and Levey-Jennings graphs.

Control orders may be single or multi-constituent

 Controls may be Abbott or non-Abbott

Accuracy is defined as how close a result is to the target or expected


result. Laboratories use QC to evaluate accuracy and acceptability of
sample results.

 Note: When samples are ordered the system software calculates


the minimum sample cup volume required for testing.
· Only a printed Orderlist provides the required testing volume for
each sample dilutions and replicates for a specific assay during the
ordering process.

QC Summary Screen:

 Used to evaluate statistics on configured controls

 Select a column header to organize the displayed QC data

 Data may be printed or displayed as a Levey-Jennings graph

Levey-Jennings Graph:

 A trend plot of data for a selected control

 Displays plotted data within a range of ±3 SD from the specific


configured assay mean

 Should be monitored for shifts, trends, accuracy, precision, and


other quality performance indicators

 Reference: For related procedures, see Alinity ci-series Operations


Manual > Section 5: Operating instructions > Specimen,
calibration, and control orders > Orders screen > Create Order
screen > Create a control order and Section 5: Operating
Instructions > Quality Control (QC) analysis

 Stored Calibrations

Assay calibrations are stored by the system after the run is completed
and displays as one of the following status types:

Active: values are within specifications and the system software will
calculate patient and QC results from this curve 1 calibration curve is
stored per lot number

 Four different reagent calibration curve lot numbers are stored at


one time before overwriting information of the oldest stored curve

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Inactive: older, previously active curve superseded by a more


recent calibration; an inactive curve status is displayed only on the
Calibration History screen

Failed: calibration values fall outside specifications; if an active curve


exists for a reagent lot, the system software calculates patient and QC
results from the existing active curve

 Reference: See Alinity ci-series Operations Manual > Section 6:


Calibration procedures > Calibration guidelines.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-25
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Assay Precision
Time: 10 mins Precision indicates the reproducibility or how well an assay or a system
provides the same result when a given sample is tested repeatedly
over time.

Service uses two precision methods for different evaluations.

 Performance Verification (PVT): an installation only verification


check to the factory

 Total Precision: package insert supported claim to verify system


and assay performance snapshot
 A more realistic assessment of the performance should ideally
incorporate performance over time.

 Reference: See Alinity ci-series Operations Manual > Appendix A:


Verification of assay claims > Precision for procedures to evaluate
precision.

 Reference: See ISA 210-001/E Alinity c Installation Procedure,


Operation Qualification- Performance Verification Testing (PVT)

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Assay Processing Activities

Activity: Basic Run Tasks and Assay Calibration Order

Time: 60 mins Purpose: To familiarize participants with assay installation,


configuration, and calibration as part of system installation.

Materials Needed:
 Reagents, Calibrators, Controls
 Sample Cups
 Racks
 Bulk solutions
 Daily Maintenance Cartridges
 Smart Wash Solutions

Service Tips:
 Toshiba manufacturing requires all new systems to pass the PVT
acceptance criteria prior to shipping. Performing the PVT during
new system installation verifies that issues have not occurred as a
result of shipping and/or the installation process.
 Daily Maintenance procedure initialized the DAQ Board during
system installation and DAQ Board replacement.

Actions: Perform the following steps to install and configure assays.

 Reference: See ISA 210-001/E Alinity c Installation


Procedure,Operation Qualification- Performance Verification
Testing (PVT) for the steps to perform the following activity actions.
Perform only the steps listed.

 Note: Some actions may not be required for this training activity,
but should be reviewed in class.

Perform the following:


 Prepare solution
 Load solutions
 Load reagent supply center solutions as needed
 Update system supply status
 Load reagents
 Configure calibrators
 Create a calibration order
 Load the calibrators into the rack
 Start the calibration

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-27
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

 Verify calibration

 Note: Skip steps for creating PVT panels for assay, as this will be
done on Day 4.

 Refer to assay parameters in the configuration for assay system


parameters.

Discussion: Assay installation and calibration will be required as part


of installation verification and may be required during a service call.
Participants need to be comfortable with performing these operation
procedures. Check for understanding by observing the activity and
clarifying any key points.

Activity: QC Analysis

Time: 30 mins Purpose: To familiarize participants with ordering QC and calibrations


required at a customer site to complete verification testing after
instrument repairs.

 Reference: See Alinity ci-series Operations Manual > Section 5:


Operating Instructions > Patient and Control Orders for the actions
that follow.

Actions: The participant will order and run QC:


 From Home Screen:
 Select Orders
 Select Create Order
 Select Control Tab
 Enter in Rack and Position
 Select AST, AlkP, TP, Na-C, K-C and Cl-C
 Select Control Name, Lot and Level
 Select Add Order
 On Order Status Screen, Select Print > Report Type Orderlist, to view
minimum sample volumes
 Load racks in RSM and transition instrument to Running status

Discussion: Review control results with participants and discuss any


results outside control ranges.

1-28 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Activity: Precision Run

Time: 60 mins Purpose: To familiarize participants with precision run and QC


configuration procedure to perform an assay precision run for
troubleshooting assay imprecision issue.Materials Needed:
 Reagents, Calibrators, Controls
 Sample Cups
 Racks
 Bulk solutions
 Smart Wash Solutions

 Reference: See Alinity ci-series Operations Manual > Appendix A:


Verification of assay claims > Precision for procedures to evaluate
precision.

Service Tips:
 Ensure samples and controls are devoid of foam and bubbles;
remove any if present.
 Sample cups contain 3 approximate volume lines (125μL, 500μL,
and 1400μL).
 Ensure reagents have sufficient volume to perform requested
orders.
 Place the processing module and RSM into Running status prior to
ordering samples to improve efficiency.
 Calibrations must be reordered if an error sends them to the
Exceptions.
 When viewing Results screens, select column header name to
organize data alphanumerically and easily find/sort data prior to
printing.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-29
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Actions: Configure QC to run an assay precision.

At the Home screen:


 Tap System > Configuration > Assay > Quality Control > New
control
 Select TP and tap Create
 Type the following information for the New Control: Control
 Name: FSPrec 1
 Level Name: Level 1
 Lot Number: seen on the control
 Expiration Date: Enter +1 year from current date
 Expected Mean: 5000
 Expected SD: 5000
 Tap Save and Done
 Order and run 10 replicates of TP or K using control level 2.
 Record the %CV in the space provided below and answer the
following questions.
%CV: ____________________________________________________
a. Did the results meet the Total %CV in the assay insert? Yes / No
(Circle one)

b. If no, then list two possible causes impacting the results.

__________________________________________________________

__________________________________________________________

__________________________________________________________
 Delete the control configured above.

Discussion: Where is the acceptable %CV for an assay located?


Check for understanding of the activity and clarify key points.

1-30 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

Instrument Overview and Basic Operations – Summary


Time: 5 mins

Area of Failure Common Related Errors Related Procedures/References


Control Issues,  Incorrect control/sample  Precision run (Refer also to
Control Values Out utilized ci-series Operations Manual
of Range (OOR)  Calibration instability Appendix and assay inserts)

 Probe or mixer misalignment  Calibration orders


or malfunction  Control orders
 Dirty or scratched cuvettes  Sample orders
 Reagent and/or control  Precision run
improperly handled or stored  Operations Manual > Section
 Non-performance of 5: Operating instructions >
required instrument Specimen, calibration, and
maintenance control orders > Orders screen
Calibration Issues  Operator error  Reagent, consumable,
 Bubbles or foam accessory, good lab practice
(See the Operations Manual
 Improper reagent and/or
and assay inserts)
calibrator handling
 Comparison of data from
 Improper loading of
previous dates when assay
calibrator
was performing within
 Nonperformance of required specifications
instrument maintenance
 ISA related to control and
 Probe or mixer misalignment assay troubleshooting
or malfunction
 Dirty or scratched cuvettes
 Fluidics or optics failure
Exceptions  Improper sample handling  Operations Manual > Section
 Bubbles or foam 5: Operating instructions >
Specimen, calibration, and
 Poor sample integrity control orders > Sample Status
(fibrin) screen
 Improper sample  Reagent, consumable,
collection and/or storage accessory, good lab practice
 Bulk solutions loaded (See the Operations Manual
incorrectly and assay inserts)
 Non-performance of  Instrument maintenance and
required instrument message history logs
maintenance
 Insufficient reagents
 Calibrator expired
 Hardware failure

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-31
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Review – Instrument Overview & Basic Operations


Time: 10 mins

1) What tasks require the system to be in Idle status?


 Answer:

2) Where is the TSB sticker located on the Alinity c?


 Answer:

3) Identify where to find the minimum sample volume required for


testing.
 Answer:

4) Add the sample cup volumes on the 3 lines indicated in the


graphic.

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Maintenance and Diagnostic Procedures Instrument Overview and Basic Operations

5) Using the Hardware Top View Diagram to complete the table


below it by writing the description of the item next to the item
number.

Figure: Hardware Top View Diagram

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 1-33
Instrument Overview and Basic Operations Maintenance and Diagnostic Procedures

Component
Description
Number
1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

1-34 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Power Distribution

2 Power Distribution

Estimated Time: 2 Hours

Objectives

 Identify the physical location, function, and voltages of power


distribution subsystems and components

 Perform key verification procedures and removal and replacement


procedures associated with power distribution systems

 Use service tools and diagnostic tools to interpret data and isolate
root causes of power supply and power distribution failures

Module Topics

 Power Distribution Overview


 Power Requirements
 RSM and SCM Power Supply Components

 Processing Module Power Supply Components


 Instrument Power ON/OFF Sequence
 Power System Diagnostics

 Power Distribution Activities

 Summary – Electronics Boards Troubleshooting

 Review – Power Distribution

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-1
Power Distribution Power Distribution Overview

Power Distribution Overview


The main power supplies (PS) for the SCM and Processing Module are
used to generate and distribute the AC and DC voltages within their
respective module.

The main power supply for the SCM is located behind the lower access
panel in the rear of the SCM. It provides power to the RSM and key
SCM components housed inside the SCM.

The main power supply for the c-series Processing Module is located
behind the power supply panel in rear of the instrument and contains
six internal DC power supplies (with variable resistors) and a power
distribution side panel.

Power Requirements
Time: 5 mins Review pre-site checklist information in the classroom.

 Note: A system UPS is not included in the standard install ordering


matrix.

 Reference: See ISA-214-001C Alinity ci Pre-Site for class discussion.

Review the following items in the pre-site power specifications.

 Electrical connection requirements

 Electrical receptacle location requirements

2-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Power Distribution Overview Power Distribution

RSM and SCM Power Supply Components


Time: 10 mins Delivery Method: Review the following reference material in the
classroom and components at the instrument.

 Reference: See Alinity c Service Documentation > General


Overview and Pre-Site Specifications or ISA 214-001 Alinity ci-
series Pre-site Interview and Inspection.

Component Function
SCM Main  Located at the rear of the SCM
Power Supply  Provides power to both the SCM and the RSM components
 Self-contained, auto-selecting power supply for frequency and
voltage requirements
 Input voltage range: 90-264VAC
 Input frequency range: 47–63Hz
 Provides 12VDC, 24VDC, 42VDC output
 Fuses are replaceable and have various ratings indicated on the
fuse and by the tip color
 Fuse indicator wire will pop out to identify an over current condition

 Note: Only the SCM UIC receives AC voltage

 Power switch acts as a breaker


 Diagnostic status LEDs
SCM Power  Located at front of SCM
Switch  Purpose is to reboot the following RSM and SCM components while
leaving the UIC and Ethernet Switch ON.
 Components powered OFF include:
 RSM Transport and Barcode Reader and SCM Module computer
 SCM control board
Cooling Fans  Power Supply contains Service Due LED (DS5)
 Steady ON – Fan Good
 Blinking – Replacement required
 OFF – Fan failure
 Requires periodic replacement based on internal diagnostic
maintenance timer
 Time interval set to allow scheduled service replacement prior to
failure
 Timer automatically reset when component replaced

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-3
Power Distribution Processing Module Power Components

Processing Module Power Components


Time: 20 mins Delivery Method: Review the following reference material in the
classroom and components at the instrument.

 Reference: See Alinity c Service Documentation > General


Overview KM and Pre-Site Specifications.

Topic Reference
c-series Main  Receives the incoming 200–220VAC line voltage and routes it to
Power Supply the primary side of the Power Transformer and Power Supply 7
(PS7).
 Contains LED’s for each DC power voltage (illuminated indicates
ON)
 Contains potentiometers for adjusting DC power
Table continued…

2-4 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Power Components Power Distribution

Topic Reference
c-series Main Power
Power Supply Voltage and Function Adjustable
Supply
(continued)
PS1  +5VDC Card Cage Backplane/CPU Yes
Bd/Logic
 +3.3VDC Card Cage Backplane/CPU
Bd/CMOS
 ±12VDC Pressure Sensor

 Note: The PM +12VDC is


protected by an in-line fuse.
PS2 +15VDC (1.5A) Analog Power Supply Yes
(DAQ)
PS3 +12VDC (8A) Magnetic Valve Drive Yes
Power Supply
PS4 +11.5VDC (2A) Lamp Power Supply Yes
(Adjusted to +11.45VDC at lamp)
PS5 +12VDC (38A) Peltiers or thermoelectric Yes
devices (TEDs) in Reagent Cooler

 Note: ON/OFF controlled by


Peltier Controller Board

 Note: The LED for PS5 is only


illuminated when power is
needed to cool the Reagent
Supply Center.
PS6 +24VDC (32A) SMD-Q Stepper Motor Yes
Drive

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-5
Power Distribution Processing Module Power Components

Figure: Main Power Supply Voltage Distribution

2-6 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Power Components Power Distribution

Topic Reference
Reagent Power Power
Supplies Voltage and Function Adjustable
Supply
PS7  Receives 200VAC from the c-series Yes
main power supply
 Generates 60VDC for the Servo
Motor Drive (drives the Reagent
Carousel).
PS8  Receives 100VAC from the c-series Yes
main power supply
 Generates 12VDC for the
thermoelectric devices (TED).

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-7
Power Distribution Processing Module Power Components

Figure: PS7 and PS8 Power Distribution

2-8 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Power Components Power Distribution

Topic Reference
Transformer  Transformer is tapped to allow selection of the corresponding
incoming voltage: 200VAC, 220VAC, 230VAC and 240VAC
 Provides 100VAC to the:
 6 internal Power Supplies
 SIO Driver Board for the Vacuum Pump
 Thermal Bath Controller Board for the water bath heater
 Contains a voltage selector cable or jumper that is factory set
and may require a different setting if incoming voltage is different.

 Note: The transformer voltage selector is difficult to change


the wire location.
Processing  Located on the front of the c-series Processing Module
Module Power
Switch  Removes all power from c-series Processing Module except for
the 12VDC used to cool the Reagent Supply Center.

 Note: PS5 LED may or may not be illuminated depending


on need to actively cool the thermoelectric device (TED).

CNN Board Generate the following voltages:


 +5VDC: Voltage supply of photo sensors and Servo Motor Driver
 ±15VDC: Voltage supply of LLS PCB

 Reference: See the Alinity c Service Documentation, power supply


schematic.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-9
Power Distribution Processing Module Power Components

Instrument Power ON/OFF Sequence


Time: 10 mins The Alinity ci-series requires a specific component sequence to
cycle power to minimize errors. It is important to allow the module to
completely power down at least one minute before powering on to
ensure function is restored.

 Reference: Alinity ci-series Operations Manual, Section 5


Operating instructions System cycle power, start, pause, and stop.

2-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Power Components Power Distribution

Required instrument status

 Processing module: Offline, Stopped, Warming, or Idle

 Reagent and sample manager (RSM): Offline, Stopped, or Idle.

PM ONLY SCM ONLY PM & SCM UIC, SCM & PM

 Note: *Ensure module status Is offline and remains off least 1 minute prior to
turning them back ON to prevent errors.

 **Note: Error codes will be displayed and recorded in message history.


a. To Power OFF  Turn off front c. Turn off g. Home Screen
only the PM: SCM Power SCM Power to Shutdown
 Turn OFF Main (Convenience) Switch (front Computer
breaker Switch Convenience) h. Turn off
 **Note: d. Turn OFF PM front SCM
 **Note: Error
code #8035
Error codes
displayed and
Power Switch
(front Green
Convenience
Power Switch
related to 5V recorded in
power supply history: Mode) i. Turn OFF front
and recorded
in message
history.
 - #8035 related
to 5V power for
 Note: UIC will
remain ON.
PM Power
Switch
the supply error
 Turn ON Main
 Note: PM  Note: PM
breaker
▬▬▬▬▬▬
 - 5119 (RSH
Module Load
reagent cooling
system will be
reagent cooling
system will be
Control 15V OFF. OFF.
b. To Power OFF and 5V Power
only the PM: Good)sensor
failed
 **Note:
Error codes
 Note: PM
reagent cooling
displayed and system will be
 Turn OFF Main recorded in OFF.
breaker  Turn ON front history:
SCM Power j. Power ON UIC
 **Note:
Error codes
Switch (front  - #8035 related
to 5V power for k. Turn ON front
displayed and Convenience) the supply error
recorded in SCM when log
history: on
 - #5119 RSH

 #8035 related
to 5V power for
Module Load
Control 15V and
l. Turn ON front
PM Power
the supply error 5V Power Good
but the sensor Switch
failed. m. Tap Start
 #5119 RSH
Module Load
e. Turn ON front
when module
Control 15V is at Stopped
and 5V Power SCM Power status
Good but Switch
the sensor
f. Turn ON front
failed.
PM Power
 Turn ON front PM Switch*
Power Switch*

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-11
Power Distribution Processing Module Power Components

Power System Diagnostics

Time: 10 mins Service Tips

 When cycling PS, wait until all PS LEDs are OFF plus a count to ten
before powering ON the main breaker to prevent errors.

 SCM Control board monitors voltage signals for power quality and if
an error condition is detected will disable distribution.

 SCM PS Fan Service Due LED provides status for periodic service
replacement:
 Steady ON – Fan Good
 Blinking – Replacement required within 30 days
 OFF – Fan failure

 Use Alinity c PS LEDs to identify voltage insufficiencies


 If LED is On then measure voltages outputs to ensure they meet
specifications to support functions.

 If the RSM servo motor is manually moved with the power on then
the holding current is removed from the motor to prevent damage.

 RSM Servo motor contain feedback chips and can be damaged if


assembly is moved manually with power on.

 Note: Turn off the system power to move any motor assembly to
prevent damage to the motor and assemblies with belts.

Additional key principles related to cycling power:

 When the front Power Switch is OFF on the processing module the
following will remain ON:
 Reagent carousel cooler
 Reagent container access covers
 Located at the transfer door and LLS access areas
 Reagent positioner door present sensor

Power ON the following in the order listed to avoid errors when the
main SCM Power supply is switched to OFF
1) SCM back switch
2) UIC
3) SCM front switch (wait for Home Screen to display before
powering ON)
4) PM (wait for Home Screen to display before powering
ON)

PM front switch on can be left ON so when the back switch is


powered ON the PM will come on line faster.

2-12 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Power Distribution Activities Power Distribution

Power Distribution Activities

Activity: Power Distribution Instructor-led

Time: 30 mins
Purpose: To perform service procedures related to power distribution.

Service Tips:

Changing the voltage selection is challenging and it may be


necessary to use pliers by removing one screw on the selection
terminal and pivoting outward enough to use pliers.

Actions: Locate the power supply transformer voltage selector and


verify configured voltage.

1. Power OFF instrument.

2. Remove Reagent Cooler per R&R

3. Loosen ( do not remove ) the 2 screws bracket to connector


panel.

4. Remove cables from the clamp

5. Remove the Thermistor heater Bracket, pull forward and set aside.

6. Loosen the 2 screws (do not remove them) holding the Voltage
Selection Terminal Housing and pull it forward to make the
corresponding AC Voltage selection.

7. Press down on the locking tab to release Voltage Terminal wire.

8. Insert the Voltage Selection Terminal into the closest corresponding


voltage on the terminal block.

9. Return the Voltage Selection Terminal Housing to its original


location and tighten the screws.

10. Reinstall the Thermistor Heater Bracket and the Cooling Unit.

 Refer to the AC Voltage Check/Change procedure located in ISA


210-001 ( current revision) Alinity c Installation Procedure.

Discussion: Check participant’s understanding through observation of


the activity and responses to review questions, then clarify key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-13
Power Distribution Power Distribution Activities

Activity: Main Power Supply Diagnostic Procedures

Time: 20 mins Estimated Time: 30 minutes

Purpose: To familiarize participants with diagnostic procedures related


to power supplies and power distribution.

Service Tips:

 Use plastic pot-adjuster to adjust PS potentiometers and prevent


damage.

 To prevent a short and system reboot, use caution when measuring


test points on boards to prevent multi-meter probes from touching
each other or frame of card cage.

Actions: Perform below procedures to measure the processing module


main power supply voltage as directed by instructor.
 M & D 4803 Voltage Test
 P-4022 +3.3VDC (PS1) Power Supply Measurement
 P-4021 +12VDC and -12VDC (PS1) Power Supply Measurement
 P-4024 DAQ ±15VDC (PS2) Power Supply Measurement
 P-4025 +12VDC (PS3) Power Supply Measurement
 P-4026 +11.45 VDC, (PS4) Lamp Power Supply Measurement
 P-4027 +12VDC (PS5) Power Supply Measurement
 P-4029 +12VDC (PS8) Measurement
 P-4028 +24VDC (PS6) Power Supply Measurement
 P-4029 +60VDC (PS7) Power Supply Measurement

Discussion: Check for understanding by observing the activity and


clarifying key points.

2-14 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Power Distribution Activities Power Distribution

Activity: AST Tool and Troubleshooting Scenarios

Time: 15 mins
 Abbott: This tools activity is for Abbott personnel only. Non-Abbott
participants should partner with an Abbott employee.

Purpose: To familiarize participants with using AST Tools for Global


Product Part Master (GPPM), Knowledge Management (KM) and
Ticket Code Tool (TCT) to build a repair plan and code service tickets.

Service You arrive at the laboratory at ABC Healthcare to check


Scenario the c-series instrument. The following symptoms are
observed:
 After powering on, the instrument displays Offline status
 Stepper motors do not have holding current
 Thermal breakers are fine
 All LEDs on power supply are lit.
 Reagent carousel is cool to the touch
Develop a 11. Navigate to KM database. Free text search to find the
Repair Plan first troubleshooting recommendation for the observed
issue. Write recommendation below
_______________________________________________________
12. Document the following part numbers from GPPM
and identify if they are high cost parts.
a. SCM Main Power Supply: ________________________
 Is component high cost? Yes / No (Circle one)
b. c-series Main Power Supply: _____________________
 Is component high cost? Yes / No (Circle one)
Ticket Code Refer to the Ticket Code tool to find the best Work Done
code for the resolution below.
 The FSR observed a loose power supply cable
connection on the card cage backplane and
reconnected cable

 Work Done Code: ___________________________________

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-15
Power Distribution Power Distribution Activities

Discussion: What information can be entered into the Knowledge


Management (KM) Solution Search box to “describe a problem” for
system troubleshooting?

Activity: Troubleshooting Scenario

Time: 15 mins
 Abbott: This tools activity is for Abbott personnel only. Non-Abbott
participants should partner with an Abbott employee.

Purpose: To familiarize participants with service procedures related to


power distribution.

Actions: The participant will respond to the following scenario:

Service During an installation, the processing module remains


Scenario in an Offline status after powering on. The following
troubleshooting steps were performed and the issues were
unresolved:
 Cycled power
 No holding current on processing module motor
subsystems
 The LED for PS5 is the only one illuminated
Develop a List resources in each category below to help troubleshoot
Repair Plan the error condition:
13. AST Tools:
________________________________________________________

14. Diagnostic indicators to check:


________________________________________________________

15. Other procedures and tools:


________________________________________________________

16. What do you think is the most likely cause?


_______________________________________________________

Discussion: Check for understanding by observing the activity and


clarifying key points.

2-16 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Power Distribution Activities Power Distribution

Summary - Power Distribution


Time: 5 mins

Component Common Related Errors Diagnostic Procedures

 PM Main Power Supply  Processing Module  Verify incoming


 SCM Main Power Supply and/or SCM will not power meets
power up specification
 PM and or SCM remains  Reseat power cord
in OFFLINE status  Check power supply
 No motor holding voltage indicator
current LEDs
 Verify selected
transformer voltage
matches incoming
power
 Perform applicable
procedure to
verify voltage for
PM internal power
supplies

Review – Power Distribution


Time: 5 mins

1) What voltage is supplied to the optics lamp, and which internal


power supply is supplying the voltage?

2) What voltages are generated by the CNN board?

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 2-17
Electronic Circuitry

3 Electronic Circuitry

Estimated Time: 2 Hours

Objectives

 Identify the physical location and function of components related


to electronic circuitry

 Perform key verification procedures and removal and replacement


procedures associated with electronic circuitry

 Use service tools and diagnostic tools to interpret data and isolate
root causes of electronic circuitry failures

Module Topics

 Electronic Circuitry Overview

 SCM and RSM Electronic Circuitry Components

 Alinity c Processing Circuitry & Components


 Card cage boards and fans
 Driver Box Boards
 Miscellaneous Boards

 Electronic Circuitry Activities

 Summary- Electronics Boards Troubleshooting

 Review – Electronic Circuitry

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-1
Electronic Circuitry Electronic Circuitry Overview

Electronic Circuitry Overview


Time:10 mins Control, drive circuitry, and communication on the IQ System includes:

 Printed circuit boards


 User Interface Computer (UIC)
 SCM Embedded Computer
 Instrument Module Embedded Computer
 Ethernet Switches A and B

3-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

SCM and RSM Electronic Circuitry


Components
Time: 30 mins Delivery Method: Locate the following boards on the instrument.

 Reference: See Alinity c Service Documentation > Troubleshooting


Diagnostics > Electrical for class discussion.

 Reference: See Alinity i SCM Service Documentation>Alinity ci-


series SCM Functional Description

Component Function
 SCM Control Board  Located in the upper rear
section of the SCM
 Receives power from the SCM
main power supply
 1 board in each instrument,
regardless of processing
modules connected in a
workcell (instrument)
 Functions include:
 RSM Transport motor X, Theta
and Z drive
 RSM X Drive module is a high
power module application.
 Connects up to Four Load/
Unload boards
 Uses the Load/Unload board
to communicate to the
sample positioner
 Lid safety interlock monitoring
 X servo drive power relay
 Power quality monitoring
 Service bypass for RSM
interlock

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-3
Electronic Circuitry Electronic Circuitry Overview

Component Function
RSM Computer  Located in the Rear of the SCM
(Also referred to as SCM Embedded below Ethernet Switch B
Computer)  Acts as the RSM CPU and
interfaces to the UIC via a
Ethernet switch
 Receives 12VDC voltage from
the SCM main power supply
 Firmware updates occur during
system software installation
automatically
Ethernet Switches  2 network switches located
inside the SCM.
 Handle all of the network
communication between
the UIC and the connected
modules.

3-4 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Component Function
User Interface Computer (UIC)  Located in the SCM
 Unaffected by the use of the
SCM Power Switch
 Receives 120-220VAC from the
SCM main power supply
 Provides a common centralized
user interface for the:
 Processing related
components
 RSM components
 Host computer
 Contains the Windows
Operating software (OS) and
Alinity ci-series Software
 Utilized for remote diagnostics
capabilities and system boot-up
observation
 System backup can be auto-
programmed to capture the
following files:
 Module calibrations: System
calibration files, robo.cal,
and ish.cal files
 System configurations:
default host and system
parameters
 Module database: System
database file, M&D
procedures, assay files
and calibrations, results,
and module and SCM
configuration

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-5
Electronic Circuitry Electronic Circuitry Overview

Component Function
RSM Load/Unload  Located at the left end of each RSM module section
Control Board  Provides power and detects
status of RSM 10 and 15 Slot
Sensor Boards through a single
connector
 Powered by the processing
module
 Receives 24 VDC from the
processing module power
supply This is true for IA and
CC.
 Monitors the processing module front lid sensor status for control
of the RSM Transport
 Detection of the Priority Switch and indication of the slot in the
load area to be treated as priority
 Requires a jumper setting for module identification during
installation

 Note: Up to 4 RSM modules can be configured.

RSM 2-Axis Driver  Small extension of the RSM Load/Unload Control board used
Board to isolate the rack positioner motor drivers from the rest of the
controls and indicators
 Located at the left end of each RSM load area
 Takes motor commands from the Load Control board and
converts them to high power motor drives for the two rack
positioner motors Attaches directly to a connector on the Load/
Unload Control Board
 Board contains fuses, LED’s and switches for diagnostics

 Note: Motor driver power originates from the processing


module.

RSM 10 and 15 Slot  Located above the sample rack and reagent cartridge slots on
Indicator Boards the loading area
 Driven by the RSM Load/Unload Control board according to
inputs from the RSM sensor boards which detect presence of
cartridges and sample racks
 Slot 1-10 use the 10 slot indicator board
 Slot 11-25 use the 15 slot indicator board
 Board contains LEDs for diagnostics

3-6 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Component Function
RSM 10 and 15 Slot  Located under the loading area
Sensor Boards  Two sensors used to detect:
 Rack or cartridge: optical sensor
 Tray: magnetic sensor
 Slot 1-10 use the 10 slot indicator board
 Slot 11-25 use the 15 slot indicator board
 Board contains LEDs for diagnostics
RSM Transport  Located on the RSM transport
Interface Board  Communications with the SCM Control board
 Provides transport functions as follows
 Communications with the sample and reagent bar code
reader
 RSM X home sensor
 Processing module X home sensor
 Theta and Z home sensor
 Signal pass-through for:
 Theta and Z motor drive and encoder
 Transport Arm Sensor board sensors
RSM Transport Arm  Serves as a mount for the pick or place sensor
or End Sensor Board  Interface for cartridge or sample rack sensor (SICK)
 A single connector conveys electronic signals from both sensors
to the RSM Transport Interface Board
 Board contains LED’s for diagnostics
 Located on RSM transport arm

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-7
Electronic Circuitry Electronic Circuitry Overview

Alinity c Processing Module Circuitry &


Components

Card Cage Boards and Fans


Time: 10 mins

Component Function
CPU  Contains the c-series firmware and provides communication
with the SCM
 A backup of the robotics information is stored in the CPU board
flash memory
 Controls the movement of the reagent carousel servo motor by
monitoring sensor status and sending control data to the Servo
Motor Driver.
SM AC/DC  Controls the:
Controller  12VDC valves and solenoids
 100VAC vacuum pump
 Three WMU 24VDC pumps
 RD30 DC Pump (External Probe/Mixer and cuvette wash)
 Internal Probe wash
 Water bath circulation RD20 Pump
 Three CAB’s 24VDC Transfer pumps
 Controls the three reagent Transport 24VDC Reagent Transport
motors
 Reagent transport Y motor
 Reagent transport Z motor
 Reagent positioner open/close motor
Stepper Motor  Controls 2-phase DC stepper motor, 5-phase DC stepper motor
Controller (SMC)  Sends control data to the Stepper Motor Driver Boards (SMD-Q1,
SMD-Q2)

3-8 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Component Function
DAQ  Amplifies and converts the optical and ICT analog signals to a
digital format and sends data to the SCM
 Uses stored robotics step table offsets alignment information in
SRAM memory
 Board contains a non-replaceable battery continually charged
when instrument is ON

 Note: Follow installation or board replacement procedures


to ensure stored robotic step table offsets are correct.

Continued...

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-9
Electronic Circuitry Electronic Circuitry Overview

Component Function
Pressure Monitoring  Has a digital processor that monitors the electrical output signals
(PM) from the pressure monitoring sensors during the aspiration,
dispense, and wash processes on all probes

 Note: Use ESD precaution when handling; board is highly


static sensitive.
Mech LED  Contains LEDs that indicate the status of the sensor signals input
to both the SMC and SM AC/DC controller boards
 Located on the outside of the card cage cover
Card Cage fans (2)  Replaceable
 12VDC

Driver Box Boards


Time: 10 mins

Component Function
SIO Driver Board  Controls voltage to drive the following:
 12VDC drive voltage to activate the valves and solenoids
 100VAC to the vacuum pump
 24VDC to the RD30 Water Pump (external probe/cuvette/
mixer wash) & Internal Probe Wash
Stepper Motor Driver  Receives control data from the Stepper Motor Controller (SMC)
 (2) 2-phase  Directs power to 24VDC stepper motors
Driver Boards  The 5-phase motors receive control signals via SMD-Q1.
 SMD-Q1
 SMD-Q2  The 5-phase stepper motors perform smaller movements
than the 2-phase stepper motors and are used on
 (3) 5-phase assemblies that require precise movement control.
Driver Boards
LLS Board  Used to detect contact with liquid surface by the sample and
reagent probes

 Note: All LLS pipettor circuit board LEDs should be lit when
the system is on.

 Thresholds for liquid detection are adjustable with


potentiometers located on the LLS board

3-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Component Function
Temperature Bath  The water bath temperature is monitored and controlled by the
Controller (TBC) TBC board
 The TBC monitors the status of the water bath temperature
sensor and drives a heater and pump to maintain water bath
temperature at 37°C

 Note: Water Bath temperature will be discussed in a later


section.

Servo Motor Driver  Controlled by the CPU


 Provides 60VDC to the reagent carousel servo motor
Mixer Driver  Applies voltage to produce 70Hz and 120Hz to the two Mixers
for use in the Wash Cup and Cuvette on the reaction carousel
when needed

Miscellaneous Boards
Time: 10 mins

Component Function
CNN Board  Serves as a power supply and distribution/interface for signals
between the SMC and SM AC/DC controller boards and sensors
mounted within the instrument.
 Contains 2 DC-DC converters that generate the following
voltages:
 +5VDC: Voltage supply of photo sensors and Servo Motor
Driver
 ±15VDC: Voltage supply of LLS board
Pipettor LLS  Located on the head of the pipettors
Pre-Amp Board  Amplifies the sample and reagent probes LLS signal
Optics Pre-Amp  Amplifies the signal of the photo-diode array of the optics
Board assembly and transmits the signal to the DAQ for processing; this
board is part of the Optics assembly

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-11
Electronic Circuitry Electronic Circuitry Overview

Component Function
Cooler Controller  Controls the Cooler Unit operation
Board  Monitors the internal air temperature of the Reagent Supply
Center.
 Sends temperature information to the CPU Board
 Controls the two reagent carousel lid heaters
 The heaters are placed around the reagent aspiration holes
to prevent condensation from forming around the opening
 Monitors the lid sensors for the Reagent Positioner Assembly and
the rear service access cover.
 Monitors the Reagent Coolant Bottle float sensor
Shut Board  Located to the right of the card cage
 Receives 24VDC from power supply
 Functions as a safety switch to stop the processing module
operation when the front and rear covers are open.
 Shut board is only found on the Total Wire Diagram service
documents currently.
ICT Pre-Amp Board  Receives and amplifies signals from the ICT module and
transmits signals to DAQ board
I-ref Level Detect  Connects to the IREF Cup electrode sensors to:
Board  Detect the presence of IREF solution in the IREF Cup
 Verifies IREF solution is aspirated out of the cup by the ICT probe.

3-12 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Electronic Circuitry Activities

Activity: Using Terminal Access for SCM Boot-up

Time: 20 mins Materials: 15-Pin VGA Male to VGA Male Cable (6 ft.)

Purpose: To familiarize participants with procedures to diagnose board


or connection failures.

Actions: Instructor-led group activity

I. Normal Boot Observation SCM Embedded Computer


1. Turn the SCM Power Switch to OFF.

2. Connect a VGA cable to the VGA port on the UIC monitor and the
SCM Embedded Computer VGA port.

3. Switch the monitor to view VGA by using the switch located at the
bottom of the monitor.

4. Turn ON the SCM Power Switch.

 Observe boot sequence for the SCM Embedded Computer

 Note: End message in this view will be “Tracelogger:tracelog_start:


Not supported”

 Note: Change the view to check the Alinity software screen goes
to Stopped.

 Answer the following questions.


a. What instrument status do you see?
b. What error messages are present?
c. How can this procedure be used to troubleshoot an OFFLINE
status?

1. Turn the SCM Power Switch to OFF.

2. Disconnect the VGA cable from the SCM Embedded Computer


and the SCM UIC.

3. Reconnect cables on the back of the UIC computer to the original


configuration.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-13
Electronic Circuitry Electronic Circuitry Overview

4. Turn ON the SCM Power Switch.

5. Perform a Startup when all modules reach a Stopped status.

Activity: Board Diagnostics

Time: 20 mins Purpose: Learn board-related diagnostic procedures for servicing the
electronic circuitry.

Caution: Always use ESD (electrostatic discharge)


mat when handling boards.

Activity: Remove the following boards and identify the key board
components listed.

1. Remove and review CPU board key components:

 LEDs

 Battery

 RAM

 LAN Port
a. Which LAN port connection contains a cable? __________

2. Verify board firmware revision:

 System

 Utilities

 Select Current Firmware tab


a. Command Module Control Board firmware version:
__________________________
a. Meridian Controller firmware version: ________
a. Identify the module and board name:__________

3-14 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Activity: Processing Module Boot-Up Diagnostics

Time: 15 mins Purpose: To be familiar with troubleshooting for Processing Modules


when unable to transition from STOPPED to IDLE Status

Actions: Perform the following steps and review Module


communications log file.
a. Log on as FSE
b. Cycle Power to Processing Module using the front Power Switch
c. When instrument status is STOPPED, select Start up to change
instrument status to IDLE
d. Perform the following:
i. Select System>File Explorer>C Drive
ii. Select the ICQ File displayed on right side of screen
iii. Open folder CC Instrument Controller
iv. Click on Log Folder
v. Select Module 1
vi. Select Module_Comm.log
vii. Scroll down to locate boot sequence.

 Note: Locate line starting with DAQ Card detected

 Note: The log file without a trailing number is the most current Log.

Discussion: Check for understanding by observing the activity and


clarify key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-15
Electronic Circuitry Electronic Circuitry Overview

Activity: AbbottLink

Time: 15 mins Purpose: To demonstrate AbbottLink portal

 Reference: AbbottLink Customer Training CBT

Actions: Log on to AbbottLink using assigned AbbottLink ID/password


and complete the following activities as directed by instructor:
 Navigate through AbbottLink
 View Historical Data, Instrument Notification Text
 Download Maintenance and history logs
 What is the main log collected for troubleshooting?
______________Name the two (2) ways logs can be collected.
 ____________
 ____________

Discussion: Instructor will check for understanding by observing


participants during the activity and clarifying key points.

3-16 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Electronic Circuitry Overview Electronic Circuitry

Summary - Electronic Circuitry


Time: 5 mins

Boards Common Related Errors Diagnostic Procedures

SCM  Processing Module  Observe Boot-


and/or RSM OFFLINE up using Terminal
status Access
 No Holding current on  Verify board
RSM Transport Motor communication
using CLI Diagnostics
 Check Board LED’s
 Check Ethernet
switch LED’s
and verify
communication
 Check cable
connections
 Verify the incoming
power meets
specification
Processing Module  Processing Module  Check LEDs on Card
and/or RSM OFFLINE Cage Boards
status  Reseat Board
 No Holding current on and /or cable
RSM Transport Motor connections
 Robotic Crashes  Inspect Board for
 Initialization Failures damage

 Component homing  M&D 4804 Save/


errors or time-out Restore DAQ
 Verify the incoming
power meets
specification

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 3-17
Electronic Circuitry Electronic Circuitry Overview

Review – Electronic Circuitry


Time: 5 mins

1. What voltages are maintained by the CNN board, and describe


the purpose of each voltage.
 Answer: Match the board and its function below.

BOARD FUNCTION

___DAQ Controls the Reagent Transport


stepper motors
Provides power to move the
___60VDC SERVO Motor Driver Reaction Carousel and Sample
Pipettor movement
Takes an optics read when
___SM AC/DC Controller cuvette flags signals the cuvette
is in front of the optics

___SIO Driver Board Applies voltage to drive the


reagent carousel

___5-Phase Motor Drivers Provides power to the RD30 DC


Pump

___Stepper Motor Controller Contains factory set robotic steps

2. Where is the robotic step table offset data stored and what M&D
allows you to view and edit this information?
 Answer:

3. List 2 features of the boards related to diagnostics.


 Answer:

3-18 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Robotics

4 Robotics

Estimated Time: 7 Hours

Objectives

 Identify the physical location and function of robotic system


components

 Identify errors related to the functioning of robotic system


components and relate these to appropriate service procedures

 Perform key removal, replacement, verification, and alignment


procedures

 Use diagnostic tools, interpret data, and isolate root cause of


robotics systems component failures

 Identify the functions and physical location of components in the


reagent supply center

 Perform key removal, replacement, verification, and alignment


procedures

 Use diagnostic tools and interpret data to isolate the root cause of
reagent management-related errors

Module Topics

 Robotics Overview

 Processing Center Robotics Components


 Processing Center Activity

 Reagent Supply Center Components


 Activity: Reagent Supply center

 Reagent and Sample Manager Components


 Reagent and Sample Manager Activities

 Summary – Robotics

 Review – Robotics

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-1
Robotics Robotics Overview

Robotics Overview
Time: 35 mins

Delivery Method: Review the topics in this section in class.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Valves, Motors and Sensors; LLS and Pressure
Monitoring.

The following are key features of the robotics system.

 Coordinates and controls mechanical movements

 Performs specific tasks designed to transport, mix, and clean


consumables, reagents, and samples

 Motors will have a holding current shortly after power is applied to


the instrument

 Use robotic step offset values for exact device positioning

 Optical sensors are used to identify motor position

 ·The CNN Board serves as an interface between the motor


assembly sensor signals and applicable controller board.

 Status of motor assembly sensors input to applicable controller


board can be visually monitored via LEDs on the Sensor LED board

4-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Robotics Overview Robotics

Topic Description
Robotics  Stepper motor controller board contains a generic factory set of
Calibration robotic step table data in firmware default position step numbers for
Offsets robotic positions
 Instrument-specific adjustments are made by completing robotic
calibration M&Ds
 Calibrations provide offset data for firmware position data
 After successful completion of M&D procedures, data are
automatically updated on the CPU and DAQ boards
 M&D 4804 Save/Restore DAQ Data provides options to view,
modify, save, restore and print the offset step table information.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-3
Robotics Robotics Overview

Topic Description
Motor Assembly  Optical sensors and flags are used to determine the home,
Position Sensors rotational, or vertical position of a motor driven device
 Many robotic assemblies locate the Home position by utilizing a
pitch flag on the motor drive shaft and a home flag on the device
that is being driven

 When the leading edge of the home flag enters the home sensor:
 The software starts monitoring the pitch sensor status.
 The motor continues to run until the leading edge of the pitch
flag activates the pitch sensor.
 When the leading edge of the pitch flag activates the pitch sensor:
 The motor will stop. The pitch sensor stops the motor.
 The software verifies that the home sensor is still active.
 The home flag should be approximately centered in the sensor.

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Processing Center Robotics Components Robotics

Processing Center Robotics Components


Time: 180 mins

Delivery Method: Review the following components at the instrument.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Valves Motors and Sensors for this discussion.

 Note: Many components mentioned below will be discussed


further in the Fluidics module.

Processing Center Robotics General Overview

The Stepper Motor Controller Board (SMC) controls the movement of


the 2-phase and 5-phase stepper motors

 The 2-phase Stepper Motors are driven by SMD-Q1 and SMD-Q2.

 The 5-phase Stepper Motors are driven by 5-phase SMDs and the
control signals are provided via SMD-Q1. 5-Phase Motor Drivers:
 Reaction Carousel Motor
 Sample Pipettor Rotate Motor
 Sample Pipettor Up/Down Motor

 SMD-Q1 provides 5VDC to SMD-Q2. Note: SMD-Q1 also provides


control signals to 5-phase

 The +24 VDC comes directly from PS6

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-5
Robotics Processing Center Robotics Components

12VDC Solenoids receive :


 Control signals from SM AC/DC Controller Board
 Drive voltage from SIO Driver Bd

Component Function
Reaction Carousel  Uses a 24VDC 5-phase motor to positions cuvettes for sample
processing
 Uses the following components:
 Optical home and pitch sensors
 Guide rollers use tension to hold carousel
 4 rollers – 1 adjustable guide roller, 3 fixed
 Adjustable guide roller is located by the optics assembly
and is used to adjust the optics beam height for low
reaction volume assays.
 Optical Trigger Sensor monitors positional flags on cuvette
segments
 Cuvette segment vertical flags signal proper position of
cuvette for optical read
 Adjusted during M&D 4001 Optics Trigger Sensor Check
 Reaction carousel is aligned using P-4008 reaction Carousel
alignment
 24VDC 5-phase motor
Cuvette Washer  Consists of:
 Eight nozzles, mounted on a platform, that are used for an
eight-step cuvette washing process.
 2 Optical sensors are used to tell the Stepper Motor Controller
Board (SMC) when the elevator is in the Up and Down
positions
 24VDC 2-phase motor
 Manual alignment performed via P-4009 Cuvette Washer
Alignment
 Uses alignment Tool engraved with “WASH”

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Processing Center Robotics Components Robotics

Component Function
Cuvette Washer Washes and dries the cuvettes
head and Nozzles  Front row of tubing = aspirate lines
 Back row tubing = dispense lines
 Water dispense from nozzles 1, 4, 5
 Dispense is in an umbrella spray pattern
Nozzles Functions
1  Aspirates HCW from cuvette via HCW
pump
 Dispenses degassed reagent grade type II
water into cuvette
2  Delivers a 1.3% mixture of alkaline and
water from the Wash Solution Pump.
 After the alkaline solution is dispensed
into the cuvette, it is aspirated through a
vacuum pump.
3  Delivers a 0.9% mixture of acid and water
from the Wash Solution Pump.
 After the acid solution is dispensed into the
cuvette, it is aspirated through a vacuum
pump.
4 and 5  Dispenses water into the cuvette
 Aspirates water through a vacuum pump.
6  Provides degassed reagent grade type II
water from wash solution pump to fill the
cuvette to a certain level for blank read
(cuvette integrity check)
7  Performs an aspiration of the water blank.
8  Provides final cuvette drying via:
 A porous cuvette drying tip
 Aspiration of residual water via vacuum
pump (VP1)

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-7
Robotics Processing Center Robotics Components

Component Function
Mixers Assembly Consists of two main sections :
Lower mechanical section :
 Linear slide, provides vertical drive to raise and lower the upper
assembly.
 Two optical sensors : detects when the assembly is in the correct
up or down position
 24 VDC two-phase motor
Upper section:
 2 customer replaceable Mixers blades.
 Uses the piezoelectric effect.
 Frequency applied depends on the mixer position in the
reaction carousel or mixer wash cup
 120Hz is used for faster movement/shorter travel when
down in the cuvette or wash cup
 70 Hz is used for slower movement to remove water from
the mixer in the upper position at the wash cup
 Optical sensor located in front of wash cup to detect blade
movement

 Note: The wash cup also contains an electrical sensor to


detect movement of the mixer blade.

 +24 VDC 2 phase stepper motor used to rotate the mixer


horizontally between the reaction carousel and mixer wash
cup.
 Manual alignment performed via P -4011 mixer 1 Alignment and
P- 4012 Mixer 2 Alignment
 Alignment tool labeled “STR”

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Processing Center Robotics Components Robotics

Component Function
ICT Assembly  The upper section contains:
 ICT module and holder
 Two water lines to allow 37°C water to recirculate and
indirectly stabilize the temperature of the ICT module
 Optical sensors to indicate when assembly is in the up/down or
rotational home position.
 Uses two 24VDC two-phase stepper motors to move horizontally
and vertically.
 Manual alignment performed using robotic alignment blocks:
 “ELC” labeled robotic alignment block used for the cuvette
alignment position
 “ELC-POD” labeled alignment block used for the IREF Cup
alignment position

Sample Pipettor (S)  Belts are used to drive the assembly in horizontal and vertical
movement
 Drive mechanisms use optical home and pitch sensors to tell the
Stepper Motor Controller Board (SMC) when the pipettor is in the
home position.
 Crash guard sensor located in the pipettor head is used to detect
obstacles during downward movement.
 Adjusted using M&D 4101Crash Sensor Alignment
 Two 24VDC 5 phase stepper motors for theta an Z movement
controlled by SMD-Q1
 Uses a calibration alignment tool found in the customer
maintenance kit to perform automated calibration M&D 4102
Sample Pipettor Calibration
 Calibrates to positions:
 Sample wash cup
 Sample positioner

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-9
Robotics Processing Center Robotics Components

Component Function
Reagent Pipettors  Belts are used to drive the assembly in horizontal and vertical
(R1, R2) movement
 24VDC 2-phase stepper motors controlled by SMD-Q1
 Crash guard sensor located in the pipettor head is used to detect
obstacles during downward movement.
 Adjusted using M&D 4101Crash Sensor Alignment
 Uses a calibration alignment tool found in the customer
maintenance kit to perform automated calibration M&D 4103 R1
Pipettor Calibration and M&D 4104 R2 Pipettor Calibration and:
 Reagent carousel targets
 Reaction carousel
 Pipettors are unique for R1 and R2

Caution: Remove power prior to moving the pipettors to


prevent mis-alignment of home and pitch sensors

4-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Center Robotics Components Robotics

Processing Center Activity

Activity: Robotics Systems Service Procedures

Time: 90 mins

Purpose: To practice robotics system service procedures.

Service Tips:
 Ensure the proper alignment blocks are used to prevent errors.
 Remove power to instrument before moving any pipettor to
prevent mis-alignment of home and pitch sensors.
 Use a voltmeter to measure the actual frequency at the mixer
blade cable connection.
 Ensure cuvette Washer is in the up position after performing the
alignment procedure to prevent nozzle and cuvette damage.

Actions: Instructor-led demonstration

 P-4013 Sample Pipettor Head Horizontal Alignment

Caution: Do not rotate pipettor head during the


horizontal alignment. Doing so, may cause mis-
alignment of the home and pitch sensors

 M&D 4804 Save/Restore DAQ Data

Actions: Perform the following procedures.

 M&D 4101Crash Sensor Alignment ( perform on ONLY 1 pipettor)

 Use M&D 4802 Robotics Test Tool to manually align the following
positions using the steps below:
 Sample Wash Solution Tray positions 1 & 2
 R1 Pipettor Water Bath Additive position

 Note: Ensure the deck cover is on prior to performing alignment for


Water Bath Additive position.

To align the probes from the M&D 4802 Robotics Test Tool:

 Select
 Procedures
 Diagnostics tab
 Module 1
 M&D 4802 Robotics Test Tool

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-11
Robotics Processing Center Robotics Components

 Perform

 Acknowledge software procedure key message and ensure the


key is turned horizontally

 Select
 Proceed

 Type assembly number to move:


 Sample Pipettor or R1 Pipettor

 Select:
 Home
 Move to Position – choose position for alignment
 Sample Pipettor: Sample Wash Solution area 1 and 2
 R1 Pipettor: Water Bath Additive position
 Continue
 Align
 Tap Clockwise or Counterclockwise to align the probe to
the target
 Return to Previous menu
 Down
 Vertical Adjustment (to check)
 Down or LLS Down
 UP
 Return to Previous menu
 Done
 Home
 Return
 Type 10 to End
 Select:
 Continue
 Proceed
 Done

 P-4010 ICT Alignment

 P-4011 Mixer 1 Alignment

 P-4012 Mixer 2 Alignment

 P-4009 Cuvette Washer Alignment

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Processing Center Robotics Components Robotics

 4103 R1 Pipettor or 4104 R2 Pipettor calibration

 Note: The R1 & R2 Pipettor Calibrations are similar and will be


performed as needed in class.

 M&D 5002 Mixer Vibration Test


 Mixer 1: Low frequency ________High frequency _________

 Mixer 2: Low frequency ________ High frequency ________

Discussion: Check for understanding by observation of the activity and


clarify any key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-13
Robotics Reagent Supply Center Components

Reagent Supply Center Components


Time: 30 mins

The reagent supply center provides cooled storage at a controlled


temperature for reagent cartridges, onboard solutions, sample
diluents, and frequently used calibrators and controls. Cartridges and
vial racks are loaded on the reagent and sample manager (RSM) and
are transferred to the reagent positioner by the RSM transport.

Delivery Method: Review the following components at the instrument.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Valves Motors & Sensors for this discussion.

4-14 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Reagent Supply Center Components Robotics

Component Function
Reagent  The carousel is split into 12 segments and have 72 cartridge locations
Carousel (only 70 reagent cartridge positions)
 The last segment only has four positions (67 – 70) configured for the
Calibration and Control rack.
 Two positions onboard solutions and maintenance cartridges
which are loaded into any carousel position for:
 Smart Wash
 Water bath Additive
 Cleaning Solution

 Reference: See the Alinity ci-series Operations Manual/


Principles of Operation/Smart Wash feature (c-series).

 Two robotic calibration target positions


 Cooled to 2–10°C using a liquid-cooling system (antifreeze)
 60VDC Servo motor rotates reagent carousel ring pinion gear
 CPU board controls the movement of the servo motor
 Servo Driver applies the 60VDC to drive the motor
 A magnetic home sensor is used to detect carousel home position.
Home position is used as a reference when the carousel moves a
reagent cartridge to the aspiration position or CRA door location.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-15
Robotics Reagent Supply Center Components

Component Function
Reagent  Provide closure of the Reagent Supply Center
Positioner  Position cartridges and vial racks to load in the reagent carousel or
(door) onto the loading area.
 Door alternates open and closed for the complete positioning
event
 Open Position – cartridge or rack is transferred to the loading
area reagent positioner pocket
 Closed Position – cartridge or rack is lifted by the reagent
transport
 Open Position – cartridge is lowered into reagent carousel
 Closed Position – cartridge or rack is inside the reagent
carousel
 Manual access of reagent cartridges from the carousel is available in
the event of a failure.

 Note: The door is easily damaged. Follow proper service


procedures to prevent damage to the reagent positioner door.

 SM AC/DC controller board, 24VDC driven by SMD-2


 5VDC sensors used for:
 Open and closed limits
 Door removal detection
 Detects door removal and initiates mandatory cartridge
removal and re-scan

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Reagent Supply Center Components Robotics

Component Function
Reagent  Moves Reagent Cartridges, Calibrator or Control racks between the
Transport Reagent Transfer pocket and a position on the Reagent Carousel
 Motion coordinated with reagent position
 SM AC/DC controller board, 24VDC driven by SMD-Q2
 Sensor provides an input to the CNN Board

Reagent Transport
Function
Sensors
Cartridge Present  Detect presence of a cartridge or rack
 Used in the calibration of carousel rotational
alignment to the transport
 Reflective sensor. Also known as “SICK”
sensor.
Cartridge Picked  Detects proper engagement of the cartridge
lift tab
 Optical interrupt sensor mounted on the
Reagent Transport Cartridge Load Board
Latched  Roller switch (mechanical sensor) located at
the bottom center of the lifter
 Detect proper release of the latch for each
cartridge slot in the carousel.
Calibration  Mechanical sensor wired in series with the
latched sensor
 Used for aligning the transport to the carousel

Reagent  Cover is heated to reduce the possibility of condensation forming,


Storage dripping and compromising reagents
Access
Cover  Note: Temperature will be discussed in a later section.
Heaters

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-17
Robotics Reagent Supply Center Components

Reagent Supply Center Activity

Activity: Reagent Supply Center

Time: 60 mins

Purpose: To familiarize participants with performing service procedures


related to the reagent supply center.

Service Tips:

 Ensure all reagents are properly removed prior to servicing the


reagent cooling area to prevent time loss on reagent packs.

 Follow approved service procedures to prevent damage to the


reagent positioner door.

Actions: Instructor led demonstration of Reagent Cartridge Latch


removal unless previously performed during component
discussionsActions: Perform the following reagent supply center
procedures. See the Alinity c service documentation

 R&R C1.10 Reagent Positioner Assembly

 R&R C1.09 Reagent Segment

 M&D 4701 Reagent Carousel Home

 P-4050 Reagent Supply Center Lubrication

 M&D 4703 Reagent Supply Center Test

Discussion: Instructor will check learner understanding through


observation during the activity responses to review questions, and then
clarify key points.

4-18 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Reagent and Sample Manager Components Robotics

Reagent and Sample Manager


Components
Time: 30 mins

Alinity c-series RSM Components – Standalone Configuration

Delivery Method: Review in front of the instrument.

 Reference: See Alinity c Service Documentation > Instrument


Overview > System Overview

 Overview of RSM components

 RSM Configurations

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-19
Robotics Reagent and Sample Manager Components

Component Function
RSM The following boards are related to the RSM for control and voltage. They
Electronic are described at length the Electronic Circuits module.
Circuit Boards
 Note: RSM electronic circuitry was discussed earlier.

 RSM Indicator Boards (2)


 Board LEDs describe the availability of the position or status of the
sample rack or cartridge associated with the individual positions
 RSM Sensor Boards (2)
 Identifies presence of trays, racks, and cartridges
 RSM Load/Unload Board
 Routes RSM Sensor and Indicator signals to SCM control board
 RSM Transport End Effector Boards
 Detects if rack was properly picked
Sample  Each module has two sample positioners
Positioners (2)  Rack exchange occurs between
loading area and a sample positioner
 Position samples for aspiration at the
sample pipettor
 42VDC power and control from RSM
Control Board motor driver located in
SCM
 SCM Control board provides
communication through the Load/
Unload Control board for the Sample
Positioner.
 2 axis driver board provides the power.
 Replaceable components: motors, encoders, belts, home sensors,
pockets, latches, latch springs
RSM Transport  Photo-type reader on the RSM Transport that uses a white illuminator
Bar Code beam to help read bar code labels on samples, racks, and reagent
Reader cartridges

4-20 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Reagent and Sample Manager Components Robotics

Component Function
RSM Transport  Moves racks and cartridges to and from:
 The loading area
 The bar code reader to read and identify samples, reagents, and
solutions
 Module-specific sample positioner or reagent positioner
 Consists of replaceable components:
 Roller wheels: two fixed and one spring-loaded wheels that ride on
guide rails to move transport
 Theta motor: provides transport arm rotation
 Z motor: provides transport arm up/ down movement for pick and
place of racks or cartridges
 Transport arm attached to the Z nut with a single screw. The
complete arm can be replaced if it gets damaged
 Transport Interface Board: connects power and routes signals for
transport position sensors, Bar Code Reader (BCR) communication,
and motor drives
 Motors receive 42VDC from SCM Control Board
 A flexible cable chain is used to route cables to interface board
and SCM

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-21
Robotics Reagent and Sample Manager Components

Component Function
RSM Transport Sensor Description
Sensors
Transport Arm (2  Present sensor ( reflective): detects if rack/
sensors) cartridge is present at a pick up point also
used with the RSM X calibration target to
establish X corrections for each Processing
Module
 Picked sensor ( optical interrupt): detects
if rack or cartridge was properly picked or
placed
Instrument X home Detects home flag located at the far right of
(optical interrupt) any work cell combination
 For a single processing module
instrument, the instrument X home flag is
located on the SCM.
 For a multiple processing module system,
the system X home flag is moved to the
right side of the farthest right processing
module
Processing module Detects home flag at the left of each
X home (optical processing module and is used to set the X
interrupt) position information within the limits of that
particular module.
Theta home Detects if the arm is in the theta home
position
Z home Detects if arm is fully in the up in the home
position

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Reagent and Sample Manager Components Robotics

Component Function
RSM Transport  Belt moves transport via X-Motor
X-Motor, Belt  42VDC servo motor with power and control from SCM Control Board
and Idler
Pulleys (2)  Lubricate both idler pulleys, one on left and right ends of the RSM
 Pulley wheel is lubricated with SuperLube oil during installation, during
a PM, and as needed to prevent the belt from riding up and creating
movement errors

Flex IGUS  Controls position and minimizes wear for the three cables that connects
Cable Chain power and signals from the SCM to the RSM Transport Interface Board
 Position sensors
 BCR communication
 X-motor

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-23
Robotics Reagent and Sample Manager Components

Reagent and Sample Manager Activities

Activity: RSM Service Procedures

Time: 60 mins Materials needed:

 Standard Tool Kit


 Digital multimeter

Purpose: To practice procedures associated with RSM installation,


maintenance & diagnostics.

 Note: Some procedures will be available later.

Service Tips:
 Follow the service procedure M&Ds in the order written to prevent
errors.
 Move Carrier Transport to extreme left of RSM to remove it or
perform maintenance to prevent damage to transport sensors.
 Proper Belt positioning is important for proper operation.
 M&D 1600 RSM Transport Calibration procedure aligns the Carrier
Transport position with positioner pockets, tray and Carrier positions

(Continued…)

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Reagent and Sample Manager Components Robotics

Actions: Use your service documents to find the procedures for the
components listed below. Then perform the removal and replacement
of the parts.

 Refer to ISA 210-001 Alinity c Installation procedure and Alinity c


Service documentation RSM Transport Assembly

 Belt
 Pulleys - left side only

Actions: Perform verification M&Ds for the following.


 M&D 1600 RSM Transport Calibration
 M&D 1111 Sample Pipettor Calibration (i-series)- for integrated
systems
 M&D 4102 Sample Pipettor Calibration (c-series)
 M&D 1620 RSM Bar Code Reader Test
 M&D 1610 Reagent and Sample Handler Test

 Note: For training purposes, insert only a few racks/trays for testing
to learn the M&D function.

Discussion: Check understanding and clarify activity key points.


Discuss lubricant to use on RSM components and processing module
components per approved service documentation.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-25
Robotics Reagent and Sample Manager Components

Robotics – Hardware Summary


Time: 10 mins

Hardware Symptoms/Errors Related Procedures


Cuvette  Improper washing  P-4009 Cuvette Washer Alignment
Washer  Unexpected sensor status while  D 7.06 Cuvette Drying Tip
moving down  Replace nozzles
 Broken dryer tip  Check cuvette washer sensor
 Assay imprecision function on MECH board
Pipettors  Restricted movement  M&D 4802 Robotics Test Tool
 Pipettor calibration failures  M&D 4102 Sample Pipettor
 Crash sensor misalignment Calibration

 LLS errors  M&D 4103 R1 Pipettor Calibration

 Assay imprecision  M&D 4104 R2 Pipettor Calibration

 Pressure monitor errors  M&D 4101 Crash Sensor Alignment


Mixer  Assembly crashes or  M&D 4802 Robotics Test Tool
Assembly unexpected status  M&D 5001 Mixer Alignment
 Assay imprecision  M&D 5002 Mixer Vibration Test

Reaction  Homing failures  M&D 4802 Robotics Test Tool


Carousel  Damaged motor pitch flag  P-4008 Reaction Carousel
 Damaged motor coupler Alignment and Trigger Sensor

 Movement or obstruction errors  P-4042 Reaction Carousel


Lubrication
 Damaged cuvettes and/or
segments  Check carousel sensor function on
MECH board
 Cuvette integrity check errors
Reagent  Movement or homing errors  M&D 4802 Robotics Test Tool
Carousels  P-4050 Reagent Supply Center
Lubrication
 Check carousel sensor function on
MECH board
ICT  ICT aspiration errors  P-4010 ICT Alignment
Assembly  M&D 4802 Robotics Test Tool

4-26 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Reagent and Sample Manager Components Robotics

Hardware Symptoms/Errors Related Procedures


RSM  RSM carrier transport and arm  P-2001 Bar Code Reader Alignment
movement errors  M&D 1600 RSM Transport
 Pick/place robotic errors for: Calibration
 Sample racks at the load  M&D 1620 RSM Bar Code Reader
platform or sample positioner Test
 Cartridge at reagent
positioner or reagent
carousel

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 4-27
Robotics Reagent and Sample Manager Components

Review – Robotics
Time: 15 mins

1) Complete the table below.

Component Voltage Controller Board


Reaction Carousel
Motor

RSM Transport & Motor

Reagent Positioner
Door (CRA Door)

Cuvette Washer Up/


Down Motor

2) What voltages are generated by the CNN board, and describe the
purpose of each voltage?

3) The pre-amp boards in the sample and reagent pipettors are


interchangeable. True or False? (Circle one)

4) List two symptoms that might suggest the cuvette washer is mis-
aligned.

5) Identify the abbreviation for the assembly or position in the table


below.

Robotic Step Table Offset


Type Description Abbreviation
Assembly
Position
Position
Assembly

4-28 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Objectives Fluidics

5 Fluidics

Estimated Time: 8 Hours

Objectives
 Identify the physical location and function of fluidics system
components

 Identify and describe key components of the Water Management


Unit (WMU), degasser unit, water bath, cuvette washer assembly,
and waste system

 Identify and explain key components of the sample aspiration,


reagent aspiration, and internal probe wash processes

 Relate fluidics modules to common performance issues

 Use fluidics diagram to identify how fluid flows through the system
and how waste is removed

 Perform key removal and replacement, verification, and alignment


procedures for fluidics system components

 Identify the functions and physical location of components related


to liquid level sense and pressure monitoring

 Use service tools and diagnostic tools to interpret data and isolate
root causes of fluidic system failures

Module Topics
 Fluidics Overview

 Continuous Access Bulk Solutions (CABS)

 Water Distribution System

 Processing Module Fluidics

 Processing Module Fluidics


 Water Management Unit (WMU) Overview

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-1
Fluidics Fluidics Overview

 WMU Related Components


 Process of Water bath fill, circulation and drain
 Process of Probes and mixers washing
 Fluidics Activity: Fluidics
 Cuvette Washing & Drying Process Overview
 Cuvette wash overview

 Waste removal
 Low concentration waste (LCW) components
 High concentration waste (HCW) components
 Liquid waste consolidation

 Fluidics Activity: Cuvette wash and waste removal

 ICT fluidics and sample progression


 ICT overview
 ICT diagnostics
 ICT sample processing
 ICT Activity: ICT Fluidics

 Liquid Level Sense and Pressure Monitoring


 LLS signal and detection
 Pressure monitoring overview
 Pressure monitoring components
 Syringe drives
 Pressure monitoring diagnostics
 Liquid Level Sense and Pressure Monitoring Activities

Fluidics Overview
Time: 10 mins

Delivery Method: Combination classroom and at the instrument.

The main tasks of the fluidics system are listed as below:

 Directs f ow of incoming and internal water throughout the system


for use in:
 Water Management
 Internal sample and reagent probe washing
 External sample and reagent probe washing
 Water bath f ll, circulation and drain
 Collects and removes waste fluids

5-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Fluidics Overview Fluidics

 Degassing
 Reduces bubbles within the water fluidics areas

 Waste removal
 High Concentration Waste
 Low Concentration Waste

 ICT Fluidics
 ICT Reference Solution Cup Fill
 ICT Aspiration

The fluidics system uses several electronic valves to direct fluid flow
throughout the system for use or moved to waste Valve control: SM

 AC/DC Controller Board

 Valve power: Receives 12VDC from SIO Driver Board


 Fluid flows to Normally open port when 12VDC is not applied
 Fluid flows to Normally Closed port to an area for use or move
fluid to waste when 12VDC is applied.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics

 Reference: See general fluidics overview diagram

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-3
Fluidics Fluidics Overview

Continuous Access Bulk Solutions (CABS)


Time: 10 mins

Delivery Method: Review this section in the classroom and at the


instrument.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics.

Component Function
Bulk Solutions  Bulk solutions bottles contain keyed caps and a septum that is pierced
& On-board during load process
Reservoirs  Bulk solutions bottles have keyed openings to prevent load errors

Transfer  Three 24VDC pumps located in the CABS tray assembly


Pumps  All three pumps are controlled by the SM AC/DC Controller board and
driven by the SIO driver board

Item/Description Function
1. Vent Manifold
2. Bottle Key Piercing
Mechanism and Needle
Assembly
3. Molded Cover
4. Door Hinges
5. Gear Pump/Manifold
Assembly
6. 0.5L On-Board Alk
Bottle & Level
Sensors
7. 0.5L On-Board Acid
Bottle & Level Sensors
8. 1L On-Board ICT Ref
solution & Level Sensors

5-4 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Water Distribution System Fluidics

Water Distribution System


Time: 10 mins Delivery Method: Combination classroom and at the instrument.

Review the fluidics diagram for big picture of both Lower and Upper
Fluidics functions and components.

 The components are located in the SCM under the SCM power
supply

 Incoming water is routed under the processing module(s).

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-5
Fluidics Water Distribution System

Component Function
SCM Regulator  Regulates incoming water pressure to 15-20 psi.
 Pre-site specification is 25psi minimum input

Water Distribution  Two-outlet manifold and valve used to direct regulated water to
Manifold the Water Management Unit (WMU)
 Right Port: directs water to standalone system
 Left Port: directs water to the second or integrated system

 Note: Additional modules (3 or 4) are connected to either


the unused left or right ports tee fitting.
Module Cutoff  Customer supplies regulator and pressure gauge prior to SCM
Valve water input.

 Note: Fittings should be non-brass at the water input line.

 Manual control to turn off the water to all processing modules


connected the SCM inlet water manifold

5-6 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Fluidics Fluidics

Processing Module Fluidics

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics

Water Management Unit (WMU) Overview


Time: 5 mins

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics and latest version of ISA, Alinity ci-series pre-
site interview and inspection for water specification.

The Water Management Unit (WMU) performs the following functions:

 Supplies water to the degasser

 Supplies water to the wash cups and cuvette washer

 Supplies water for the internal probe wash

 Fills the water bath

 Circulates and heats the water bath

 Drains the water bath

 Provides low concentration waste (LCW) and high concentration


waste (HCW) management

 Note: Temperature control will be discussed in the Temperature


Systems training module.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-7
Fluidics Processing Module Fluidics

WMU Related Components


Time: 15 mins

Component Function
Inlet Water Input for plumbed Reagent Grade Type II Water:
Connection 15–20psi or 0.103hPa–0.172hPa
Inlet Water  Connections located underneath left rear system corner
Valve  Two-way valve regulates incoming water
 ON (open) to FILL open water tank
 OFF (closed) to STOP incoming water flow
Flow Restrictor Restricts/slows incoming water flow rate through narrowing diameter
DI Water  9L water reservoir that fills automatically to maintain water availability
Tank & Float and enables water to be distributed throughout the instrument
Switches (3)  Water levels are monitored by float switches:
 Overflow sensor or float switch: provides alerts of an overflow
condition
 High (full) and low float switches: signal control to open/close
incoming On/Off valve
RD30 Water  24VDC motor
Pump  Provides water to:
 Probes and mixers wash cups
 Cuvette Wash Nozzles 1, 4, 5
 Electronic valve(s) located at Probe Wash Cup
 M&D 4202 Wash Cup Test Procedure used as a tool to measure
water flow to only the Sample Probe wash cup
 The water pump is constantly running when the instrument is ON and
water flow is present; this is to maintain circulation and decrease
occurrence of contamination

5-8 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Fluidics Fluidics

Component Function
Water Bath  Pump supplies degassed water to water bath
Fill Peristaltic  A float switch located inside water bath signals SM AC/DC Controller
Pump water bath is full
 Utilizes a photo-sensor and encoder
 When replacing tubing use, all supplied lubricant on the tubing
 Replaceable 12VDC 2-phase motor
Internal Probe  SIO driver board provides 24VDC via PS6
Wash 24VDC  Supplies degassed water for internal probe cleaning:
Water Pump
 Uses a common manifold to move fluid to 3 different water lines
 The water flows through a syringe, PM sensor, and probes
 Uses a two-way valve for control

 Reference: See Alinity c Service Documentation Internal Probe


Wash Diagram.
Water Heater  Supplies heated water to:
and Water Bath  Water bath
Circulation
Pump  ICT water jacket around the ICT module

 Note: Water heater will be reviewed in the Temperature


Systems training module.

 Water bath float switch


 Replaceable float switch inside water bath that signals:
 Water fill pump to fill water bath when float switch is OFF
 Water bath heater assembly pump to circulate water when
float switch ON

 Note: Error may occur if system is unleveled.

Water Bath  Filters water entering the water bath as it exits the heater
Filter  Filter is replaced during annual PM

Water Bath  Allows water bath to empty to LCW during M&D procedures
Drain Valve  SM AC/DC Controller Board supplies the control signal SIO Driver
board provides the voltage

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-9
Fluidics Processing Module Fluidics

Degasser

Component Function
Degasser  A self-contained unit used to remove air from incoming water
 Canister contains semi-permeable membrane tubing to remove air
from incoming water
 Provides pressure errors :
 High pressure error generated when tubing leaks excessive
water into canister

 Note: P-4005 Degasser Canister Draining is used to remove


excess water.

 Canister and fuse are replaceable


 Receives water from WMU and supplies degassed water to:
 Internal probe wash pump
 Wash solution pump
 The pump supplies degassed water to:
 Dilute acid and alkaline solutions for cuvette cleaning
 Nozzle 6 of the cuvette washer for the cuvette water blank
read
 Water bath fill pump
 Uses 24 VDC provided by PS 6

5-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Fluidics Fluidics

Process of Water Bath Fill, Circulation and Drain


Time: 10 mins

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics

Process Function
 The Water Bath fill Peristaltic Pump provides degassed water
into the water bath.
 A float switch in the water bath monitors the water level and
Water Bath Fill
sends signal to module when the water bath is full.
 The water bath fill Pump turns OFF and the Circulation Pump
and Heater turn ON
 The Water Heater and Water Bath Circulation Pump maintain a
constant water bath temperature of 37°C by re-circulating the
water from the bath through the pump, into the Water Heater,
Water Bath through a manifold and back to the water bath in a closed
Circulation loop.
 The manifold has a port that provides re-circulated heated
water to the ICT Warming Jacket to keep the ICT module
warm.
Water bath The Water Bath Drain Valve is used to direct the bath water to the
Drain LCW External Waste Port.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-11
Fluidics Processing Module Fluidics

Process of Probes and Mixers Washing


Time: 10 mins

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics

Components Description/Component
Internal Probe  When it is necessary to wash the probes internally, the Internal Probe
Wash Wash Pump and the 2- way sample reagent valves turn ON.
 Valves are driven by 12VDC provided by the SIO Driver Board
 Degassed water is pumped through the syringe blocks, PM Sensors
and out of the sample and reagent probes.
 Upon completion of a probe wash cycle, the pump turns OFF and
the sample reagent valves close. The 3- way valve on the sample
line directs a small amount of water to the water bath overflow
compartment to relieve pressure in the line.

5-12 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Fluidics Fluidics

Components Description/Component
External Probe  The RD30 Water Pump pumps water in a re-circulating closed loop
Wash from the water tank, to a manifold and 3-way valve and back to the
tank.
 The Water Pump is constantly running to maintain circulation. When
the valves open, water is directed to the cuvette washer nozzles and
probe and mixer wash cups.
 An adjustable needle valve is used to set the sample probe external
wash volume.
 The wash volume for the mixers and reagent probes are not
adjustable. The flow rate is based on the pump output and tubing
size.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-13
Fluidics Processing Module Fluidics

Fluidics Activity 1

Activity: Fluidics

Time: 60 mins

Materials Needed:

 Standard Tool Kit  Cotton tip swabs


 Spare water bath fill pump  10-25mL syringe tubing
tubing  50-100mL graduated cylinder
 Spare water bath filter  Absorbent towels
 Spare water bottles  100-500mL waste beaker
 Bleach  Gauze
 Type 2 water
Purpose: To practice performing procedures related to fluidics
components and maintenance.

Service Tips:
 Use all lubricant on water bath pump head tubing during
replacement and ensure tubing is installed without being twisted
 During Wash Cup test, ensure:
 Review M&D instructions prior to starting
 Syringe valve cable is disconnected prior to beginning test and
reconnected at the end to avoid errors
 Needle valve locking ring is loosened to adjust the valve and
secured after the adjustment

Actions: Perform the following procedures.


 Replace the Cuvette Dry tip (use ci-series Operations Manual
customer procedure)
 R&R I1.11 Tubing, Pump Head, Water Bath Fill
 R&R I1.12 Water Bath Filter
 P-4005 Degasser Canister Draining
 M&D 4202 Wash Cup Test
 M&D 4209 Internal Probe Wash Pump Test

Discussion: Instructor will check for participant understanding and


clarify key points.

5-14 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Processing Module Fluidics Fluidics

Cuvette Washing & Drying Process Overview


Time: 15 minsReference: See Alinity c Service Documentation >
Instrument Overview > Fluidics

Cuvette washing is an 8 step process is used to clean the cuvettes

 Sample and reagent from previous reactions is aspirated to a high


concentrate waste container or drain.

 Cuvettes are washed with alkaline and acid wash solutions and
then rinsed.

 After the water rinses, it dispenses water for a water blank reading
and then dries the cuvette prior to the next sample.

Process Description
Cuvette  The RD 30 Water Pump in the WMU pumps water in a recirculating
Water Wash closed loop from the water tank, to a 3-way valve and back to the
tank.
 The Water Pump is constantly running to maintain circulation.
 When the 3-way valve opens, water is directed to the cuvette washer
nozzles 1, 4 and 5. An adjustable needle valve (prior to the 3-way
valve) is used to set the wash volume.
 Nozzle 6 dispenses degassed water that is used for the water blank
read. The center position 1-ml syringe on the Wash Solutions Pump
provides the degassed water to nozzle 6.

Cuvette  The Wash Solution Pump dilutes the alkaline solution to 1.3% and the
AlKaline and acid solution to 0.9% and then distributes the solutions to the nozzles for
Acid Wash the cuvette washing.
 Wash solution Pump consists of:
 Three 1mL syringes and check valves (blue)
 Two micro syringes:
 Aspirates and create dilution of Alkaline and Acid solutions
 Utilizes 4 valves: ALK1, ALK2, ACD1, ACD2

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-15
Fluidics Processing Module Fluidics

Process Description
Cuvette AlKaline  On the down stroke of the pump:
and Acid Wash  Degassed water from the Degasser Unit is supplied to the two
1mL syringes through check valves mounted at the top of
each syringe.
 At the same time, the ALK1 and ACD1 valves turn on (NC is
open, NO is closed) allowing aspiration of straight alkaline
and acid solution from the bulk solution bottles into the micro
syringes.
 The 1mL syringes filled with water and the small, measured
amounts of alkaline and acid solutions in the tubing lines
create the proper dilutions to be delivered to the cuvette
washer nozzles.
 On the up stroke of the pump:
 Valves ALK1 and ACD 1 turn off (NC is closed, NO is open)
and valves ACD2 and ALK2 turn on (NC is open, NO is
closed), allowing the solutions to be pumped into the nozzles
2 and 3 of the cuvette washer.
 At the completion of the cycle, valves ALK2 and ACD2 turn
off (NO open, NC closed), allowing any remaining solution
or air to be directed to the low concentration waste tank
through the valves normally open port..

Cuvette Washer  A dual headed vacuum pump is used to remove the contents
Waste and Drying of the cuvettes and provide a final drying before the cuvettes
are used again. The vacuum pump has two heads that are
identified as VP1 and VP2.
 VP1 is attached directly to the cuvette dryer tip and provides
final drying.
 Aspirated water is directed through the vacuum pump to the
LCW tank in the WMU.
 VP2 aspirates water, diluted alkaline and acid wash solutions
from the cuvettes into the nozzles through a manifold and
directs it to the LCW tank in the WMU.

5-16 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Waste Removal Fluidics

Waste Removal
Time: 15 mins

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics and Troubleshooting and Diagnostics > Liquid
Waste Management

Low Concentration Waste (LCW) Components


Component Function
LCW Tank and  Collects LCW and drains the waste out of the instrument
Float Switch  Part of WMU
 Tank also has a separate overflow port to an external fitting should it
overflow
 Receives reagent refrigerator condensation and open water tank
overflow
 Microbial growth can cause tubing and elbow obstruction in LCW
tank; remove tank and clean with bleach
 Waste line microbial growth does not affect system performance
unless an obstruction occurs
 Full LCW errors can be caused by dirty LCW float switch; clean with
0.5% sodium hypochlorite to resolve

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-17
Fluidics Waste Removal

High Concentration Waste (HCW) Components

 Reference: See Alinity c Service Documentation > Instrument


Overview > Fluidics and Troubleshooting and Diagnostics > Liquid
Waste Management

Caution: HCW may contain patient samples.

Component Function
HCW Pump  Peristaltic style pump; different than water bath fill pump tubing
 Provides aspiration of waste from cuvettes to optional HCW container
or drain
 HCW aspirated by nozzle 1 on the cuvette washer
 24VDC 2-phase motor
 Controlled by the SMC board and powered by the SMD-2
 Uses a photo-sensor and encoder
 Replaceable
 Ensure all lubricant is used during tubing replacement
ICT Aspiration  Aspirates HCW from ICT HCW cup through a check valve to HCW
Pump container or external drain

 Note: Additional function of ICT aspiration pump will be covered


later in this section
HCW Bottle  Optional feature to collect HCW
 Requires system configuration change

5-18 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Waste Removal Fluidics

Liquid waste consolidation


Component Function
Liquid Waste  Connections for all integrated ci-series modules:
Consolidation  i-series processing modules: collects both gravity and pressurized
Manifold waste
 c-series processing modules: collects pressurized High and Low
Concentration waste
 The gravity drain remains separate from the pressure drains until it
reaches an atmospherically vented customer drain point or vented
external collection pump. Only the c-series will be discussed in this
training.
 Pressurized Waste:
 High Concentration Waste
 HCW will be diverted to the HCW Bottle, if used
 High Foaming Waste
 Gravity Waste:
 Low Concentration Waste Tank
 Overflow Waste

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-19
Fluidics Waste Removal

5-20 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Fluidics Activity 2 Fluidics

Fluidics Activity 2

Activity: Cuvette Wash, Syringes and Waste Removal

Time: 80 mins

Purpose: Be familiar with procedures related to cuvette washing,


drying & troubleshooting.

Actions: Perform the following cuvette wash key procedures:


 Inspect wash head tubing for kinks/discoloration
 Replace the Cuvette Dry Tip (use Alinity ci-series Operations
Manual > Section 9 Component Replacement )
 P-4002 Cuvette Wash Flow

Actions: Perform the following syringe maintenance procedure(rebuild


only one syringe as designated by the instructor):

 M&D 5801 Sample Syringe Maintenance

 M&D 5802 Wash Syringe Maintenance

 M&D 5803 Reagent Syringe Maintenance

 M&D 4205 Flush Water Lines

Actions: Perform the following key procedures related to waste


removal (instructor-led demonstration):
 R&R F8.02 Vacuum Pump, diaphragm, sheet valve and O-ring
 Perform M&D 5910 Wash Cuvettes and answer questions below:
a. If you observed a single cuvette overflowing, what would you
suspect as the potential cause?
____________________________________________________________
____________________________________________________________
b. If multiple cuvettes were observe overflowing, what would you
suspect as the potential cause?
____________________________________________________________
____________________________________________________________

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-21
Fluidics Fluidics Activity 2

Activity: Simulated Troubleshooting Scenario

Time: 15 mins
Actions: Perform one of the following scenarios:
 Clamp off VP2 line to induce a multiple cuvette overflow.
 Clamp off Cuvette Washer Nozzle drain tubing to vacuum
pump to induce a single cuvette overflow.
 Replace the HCW Pump tubing with a slightly damaged (cut)
tubing to induce Cuvette Washer nozzle 1 overflow and leak in
the HCW Pump head.

Record your observations below:

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

Activity: AST Tools Service Scenario

 Abbott: The tools actions below are for Abbott personnel only.
Non-Abbott participants should partner with an employee.

Time: 15 mins Actions: Perform AST Tool service scenario.

During daily service cadence activities you received a POM alert


for error code of "Unexpected sensor status for internal water tank"
occurring at a hospital in your CRL.

Based on the above error code, list the steps to access the KM article
for recommended troubleshooting or related service documents.

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

Discussion: Debrief activity and highlight key learning points; clarify


questions and reinforce learning.

5-22 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
ICT Fluidics and Sample Progression Fluidics

ICT Fluidics and Sample Progression

ICT Overview
Delivery Method: Review and discuss in front of the instrument
Time: 20 mins
ICT methodology uses solid state ion-selective electrodes contained in
a single chip (ICT module) and reduces maintenance.

 Reference: See Alinity c Service Documentation > General Data


> Fluidics Overview > ICT Aspiration Pump Fluidics and ICT
Reference Solution Pump Fluidics for this discussion.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-23
Fluidics ICT Fluidics and Sample Progression

Component Function
ICT Reference  Delivers and removes ICT reference solution (IREF) from ICT reference
(IREF) Solution solution cup (IREF cup)
Pump  Pump is driven by a 24VDC 2-phase motor.
 Consists of 2 syringes with orange check valves
 Syringe #12
 Delivers ICT reference solution through water bath warming ring
and into IREF cup
 Syringe #12 should be free of bubbles
 Syringe #13
 Aspirates remaining solution from IREF cup and moves it into
water bath/waste overflow
 Syringe #13 may normally contain bubbles
 Syringe tubing connected to incorrect locations (connected in
reverse) will result in IREF cup overflow
 IREF solution leaks cause syringe plunger to stick to the platform, know
how to clean it
 ICT fluidics are common customer errors
 IREF solution Cup Fill and IREF Solution not Aspirated are the common
errors
ICT Warming  Warms IREF solution to 37°C before it fills IREF cup
Ring  Holes in warming ring may impact voltage readings
Caution: Follow approved procedures for cleaning water bath to prevent
errors, warming ring holes, and ICT result issues.

IREF Cup &  Contains preheated ICT reference solution aspirated by ICT probe and
Electrodes measured by ICT module
 Contains two electrodes for capacitance level sensing
 Ensure spatial arrangement of ICT LLS electrodes remains
unchanged to prevent ICT cup aspiration errors

5-24 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
ICT Fluidics and Sample Progression Fluidics

Component Function
ICT Aspiration  Used to aspirate sample or ICT Reference Solution into the ICT Module
Pump for measurement.
 Consists of two 1mL syringes
 Syringe #11
 Aspirates samples or ICT reference solution into ICT module for
measurement and pumps it into ICT waste cup
 Syringe #11 should be free of bubbles
 Syringe #15
 Aspirates waste from water bath waste area and pumps it out
the HCW line
 Only syringe #15 has a check valve (orange)
 Pump driven by 24VDC two-phase stepper motor.
 ICT aspiration or pinch valve (3-way valve) directs the sample flow
from ICT probe to water bath waste area

 Note: The ICT pinch tubing will need to be seated in the valve
during the installation process.

 Ensure NO & NC tubing are placed in the correct positions to


prevent errors

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-25
Fluidics ICT Fluidics and Sample Progression

Component Function
ICT Module  The ICT probe:
 Aspirates diluted sample from the cuvette
 Aspirates ICT reference solution from the IREF cup into the ICT
module for processing
 ICT (integrated chip technology) measure sodium (Na), potassium (K),
and chloride (Cl) simultaneously
 Uses solid state ion-selective electrodes contained in a single chip
to reduce required maintenance
 The ICT module manufacture date is determined from serial number
on the module as follows:
The table below shows how the ICT serial number breaks down.

100515042
10 05 15 042
Year made Month made Day made Sequence #

 Newly installed ICT module calibration curve slope is approximately


80–100.
 ICT Modules expire 9 months from the manufacturing date on the
module.
 Calibration slope normally decreases with time and use
 Replace the module when:
 Module is expired
 Calibration slope is <45 and error is generated
 ICT assay precision and/or QC is outside of laboratory
requirements

5-26 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
ICT Fluidics and Sample Progression Fluidics

Component Function
IREF Level
Detect Board

 Detects presence of IREF solution in IREF cup


 Receives detection signal from electrodes
 Contains two LEDs
 LED2: (top LED) Read Status
 LED1: (bottom LED) Cup Full
 LED observations are valid during sample processing only. Level
Detect Board LEDs are only active as noted above for the M&D to
Flush the Cup.
 IREF Level Detect LED Sequence:
 Immediately before ICT assembly moves down and aspirates ICT
reference solution from cup:
 LED 2 Read Status: flashes ON
 LED1 ICT Reference Cup Full: flashes ON
 Immediately after ICT assembly and pump aspirates IREF solution from
cup:
 LED 2 Read Status: flashes ON
 LED 1 ICT Reference Cup Full: remains OFF

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-27
Fluidics ICT Fluidics and Sample Progression

ICT Diagnostics
Time: 10 mins

5-28 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
ICT Fluidics and Sample Progression Fluidics

ICT Sample Processing

 Reference: See Alinity c Service Documentation > Instrument


Overview > ICT Overview.

Time: 10 mins During ICT sample processing, the following events occur:

1. Sample and ICT sample diluent are dispensed into a cuvette.


 Sample pipettor dispenses 15μL of sample into the cuvette
 Reagent pipettor 1 dispenses 69μL ICT sample diluent (ICTD5)
and 276μL of water into the cuvette
 Mixer 1 mixes the sample and diluent
 Reaction carousel continues to rotate until cuvette aligns with
ICT unit approximately after 37 reaction carousel movements

2. Sample is analyzed.
 ICT unit moves out and down
to position ICT probe in the
cuvette
 ICT aspiration pump Syringe
#11 aspirates cuvette
contents into ICT module
 ICT module measures sample
 System converts
measurements into millivolt
readings used to calculate
sample results.
 ICT pre-amp amplifies
signal
 DAQ board converts
reads to a digital signal
 CPU sends digital data to SCM UIC
 SCM UIC calculates the final sample results using stored
calibration data

3. Waste is removed.
 ICT aspiration pump Syringe #11 moves sample from ICT module
to HCW compartment
 ICT aspiration pump Syringe #15 aspirates liquid waste from
HCW compartment
 ICT aspiration pump Syringe #15 moves liquid waste to HCW
tubing

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-29
Fluidics ICT Fluidics and Sample Progression

ICT Fluidics Activities

Activity: ICT Fluidics

Time: 60 mins

Purpose: To practice procedures related to the ICT subsystems.

Materials Needed:
 Standard Tool Kit
 Cotton Swabs

Service Tips:
 Only hand-tighten the ICT Module to prevent errors.
 Syringes on both ICT pumps (should be free from bubbles on the left
side to prevent errors.

Actions: Perform the following;


 R&R D2.03 Pump Pinch Valve, ICT Aspiration
 P-4037 Clean ICT Reference Cup and LLS Electrodes
 ICT Module (See the procedure in the Online Operations Manual)

Reference: See Alinity ci-series Operations Manual, Section 9.

 M&D 5101 Flush ICT Reference Solution Cup


 M&D 5102 Flush ICT Module

Actions: Remove ICT aspiration tubing from the pinch valve; perform
the following M&Ds

1. ICT Diagnostics, M&D 5101 Flush ICT Reference Solution Cup


a. What error was generated?
__________________________________________________________
b. What components are involved with this M&D?

__________________________________________________________

__________________________________________________________

5-30 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
ICT Fluidics and Sample Progression Fluidics

2. M&D 5102 Flush ICT Module


a. What error was generated?
__________________________________________________________
b. What components are involved with this M&D?

__________________________________________________________

__________________________________________________________
 Reinstall pinch valve tubing and perform the following procedure
until the error is resolved:
 M&D 5102, Flush ICT Module

Discussion: Check understanding and clarify key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-31
Fluidics Liquid Level Sense and Pressure Monitoring

Liquid Level Sense and Pressure


Monitoring
Time: 45 mins

Delivery Method: Discuss the following topics in class.

 Reference: See Alinity c Service Documentation > Instrument


Overview > LLS and Pressure Monitoring for this discussion.

Liquid level sense (LLS) and pressure monitoring (PM) are used to
detect liquid and ensure sample and reagent liquid aspirations occur
without error during assay processing.

 LLS hardware is used to detect when the pipettor probe makes


contact with liquid.

 Pressure monitoring is performed during:


 Aspiration
 Dispense
 Washing

5-32 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Liquid Level Sense and Pressure Monitoring Fluidics

LLS Signals and Detection


 CNN Board provides ±15VDC to LLS board to generate LLS signals

 LLS system applies a constant signal to the probes

 When the probe touches liquid, a signal change is detected and


system begins to aspirate fluid
 Sample & Reagent pipettors continues 2mm past surface of
liquid once liquid is detected to attempt aspirations of only
liquid

 LLS signals are monitored throughout aspirations, and errors are


generated when changes are outside of specifications

 LLS signals are monitored for any change after liquid is detected

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-33
Fluidics Liquid Level Sense and Pressure Monitoring

Pressure Monitoring Overview

 Reference: See Alinity c Service Documentation > Instrument


Overview > LLS and Pressure Monitoring for this discussion.

Pressure Monitoring (PM) hardware is used to determine that the


correct volume of liquid is aspirated and clots, bubbles, or other
interference is absent during liquid aspiration.

PM is accomplished by placing a pressure transducer in the fluid


line between the syringe and probe, then analyzing whether liquid
aspiration conforms to a normal pattern.
 Abnormal PM profiles will generate an aspiration error

5-34 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Liquid Level Sense and Pressure Monitoring Fluidics

Pressure Monitoring Components

 Note: PM Board was previously discussed.

Component Function
Pressure Sensor  Contains piezoelectric sensor and an internal preamplifier board
 Field-replaceable part
 Signals from fluid flow are sent to the Pressure Monitor board for
evaluation
 Fluid flow is monitored by the PM system during probe aspirations,
dispense, and probe washes for detection of clots, foam, or bubbles
Pressure  Pressure is monitored for the sample/reagent probes during:
Monitor Board  Sample/Reagent aspiration and dispense
 Internal probe wash cycle
 PM data collected by the system reflects the fluid pressure in the
probes, tubing, syringes, and manifold

 Note: The Sample, R1, & R2 syringes connect to an open


common manifold and components can induce errors. It is
recommended to troubleshoot any component attached to
the manifold to assist in a resolution.

 Note: PM log data may be evaluated using LOG-ICAL.

 Pressure monitor board added to card cage during installation


 Comparative pressure data are stored in software files on the SCM
UIC
 M&D 4112 Pressure Monitor Test checks the pressure monitor
board and pressure monitor transducer for communications and
consistency

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-35
Fluidics Liquid Level Sense and Pressure Monitoring

Syringe Drives
Component Function
Syringe Drives  Provide aspiration and dispensing of sample and reagent
 Sample (S)  24VDC 2-phase motor drives plunger up/down
 Reagent 1  Only reagent syringe drive assemblies are interchangeable
(R1)  Sample syringe block and internal components are different than the
 Reagent 2 R1 & R2 syringe block
(R2)  O-rings and seal tips are replaced during customer Quarterly
maintenance

5-36 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Liquid Level Sense and Pressure Monitoring Fluidics

Pressure Monitoring Diagnostics


Pressure Monitoring errors can occur on:

 Probe aspiration and dispense

 Internal probe washing

PM Error Descriptions

 Unable to process test, aspiration or dispense error

 Unable to initialize run/ initialize run, wash error occurred

 Unable to process test, aspiration or dispense error at a pipettor &


position

 Unable to process test, wash error occurred at a pipettor & position

 Unable to process test, internal wash pressure error at a pipettor

 Unable to process test, reagent 1 or 1 aspiration error occurred

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-37
Fluidics Liquid Level Sense and Pressure Monitoring

Liquid Level Sense and Pressure Monitoring Activities

Activity: LLS and PM Troubleshooting Procedures

Time: 30 mins

Purpose: The participant will practice robotics troubleshooting


procedures.

Actions: Perform the following robotics procedures that may be used


during troubleshooting.
 M&D 4101 Crash Sensor Alignment (perform on ONLY 1 pipettor)
 P-4020 LLS Voltage Adjustment
 Check and record the LLS frequency at sample or reagent probe
Sample: ____________________
R1: _________________________
R2: _________________________

Discussion: Check for understanding by observation of the activity and


clarify any key points.

Activity: Troubleshooting Scenario

Time: 15 mins

Purpose: The participant will practice troubleshooting by using service


tools in service situations.

Actions: Complete the service scenario below.

Troubleshooting Scenario

The lab supervisor at Aventura Medical has contacted the Support


Center regarding error 5745 R2 Pipettor Movement Restricted at
Reagent Supply Center Position A4, which has occurred intermittently
over the past week.

It is now causing the system to go into Stopped status. The supervisor


said the lead tech has performed the following troubleshooting
without resolution and requested service.
 Confirmed all cartridges have caps removed
 No obstructions noted
 Replaced probe
 Probe calibration failed
 Daily Maintenance was successful that morning(Continued…)

5-38 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Liquid Level Sense and Pressure Monitoring Fluidics

Develop A Repair Plan

 Abbott: The following actions are for Abbott personnel only. Non-
Abbott participants should partner with an Abbott employee.

1. Navigate to the Alinity c Service Documentation and list available


resources you could use to help in the isolation of the cause of the
above failure.

_________________________________________________________________

_________________________________________________________________

GPPM and Part Coding

If the issue was determined to be due to a damaged crash sensor and


resolved by replacing part, navigate to GPPM, locate and record the
P/N for the crash sensor below.

_________________________________________________________________

HCP (High Cost Part) Activity

If the R2 pipettor was identified as the cause of the issue, complete the
following using GPPM as a reference tool:

1. What is the GPPM factory standard cost for the part?

_________________________________________________________________

2. Is the reagent pipettor a high-cost part? Yes / No (Circle one)

3. What GPPM indicators are available to inform you the part is an


HCP?

_________________________________________________________________

4. Where do you find the process to get the HCP approved?

_________________________________________________________________

Discussion: Instructor will check learner understanding through


observation during the activity and responses to review questions, then
clarify key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-39
Fluidics Summary – Fluidics

Summary – Fluidics
Time: 10 mins

Hardware Symptoms/Errors Procedures/References


WMU  Incoming water errors  Clean LCW tank float switch
 LCW tank  Low concentration  R&R water bath fill tubing, valve
 Water Bath Fill waste tank full  Check inlet water quality
pump  Water bath fill errors
 Inlet on/off  DI tank failed to fill
valve
 Cuvette Washer  Assay imprecision  P-4009 Cuvette Washer Alignment
 Cuvette Wash  Improper washing  M&D 4209 Cuvette Washer Test
Pumps  Leaking and dripping  M&D 4208 Pump/Valves Test
 Wash Solution nozzle  R&R D7.06 Cuvette Drying Tip
Pump  Cuvette overflow  R&R D5.03 Valve, Wash Solution
 Discolored streaks or  Replace nozzles
chips on dryer tips
Note: Dryer Tip damage is
mostly likely due to Cuvette
Washer mis-alignment
 Sample/  Assay imprecision  Replace and/or calibrate probe
Reagent Probes  LLS errors  M&D 4202 Wash Cup Test
 Wash Cups  Pressure monitoring errors  M&D 4102 Sample Pipettor
 Needle Valves  Pipettor calibration Calibration
failure  M&D 4105 Sample Probe and
 Low water volume or no Rack Alignment Test
water to wash cups  M&D 5801 Sample Syringe
Maintenance
 M&D 5803 Reagent Syringe
Maintenance

5-40 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Summary – Fluidics Fluidics

ICT Fluidics
ICT Aspiration  ICT Ref Solution Not  M&D 5102 Flush ICT Module
Pump Aspirated error  M&D 4208 Pump/Valves Test
 ICT assay result  P-4010 ICT Alignment
imprecision,
calibration failure
 ICT assay calibration
failure
ICT Reference  Bubbles in syringe  M&D 5101 Flush ICT Reference
Solution Pump #12 and/or ICT cup Solution Cup
fill errors  M&D 4208 Pump/Valves Test
 Erratic ICT results  M&D 5804 Replace 1mL Syringes
 IREF cup overflow  Inspect/replace check valve
ICT Result  Unable to calculate  ICT module cable failure or loose
Troubleshooting results, ICT Reference connection
Solution voltage drift  ICT Preamp board failure
errors
 M&D 5101 Flush ICT Reference
 Unable to calculate Solution Cup
results, mV reading
outside measurable  M&D 5102 Flush ICT Module
range of ICT
assembly

LLS Error Descriptions

 “Liquid Not Found” – error generated when Pipettor travels to lower


step limit without detecting liquid.
 “Liquid Contact Broken for X Pipettor” – error generated when
(after liquid detection and aspiration into the probe) the LLS
circuitry detects a change of phase, due to the loss of liquid (prior
to dispense).
 “Sample Pipettor Error While Moving Down” – error generated when
Crash Sensor is activated as Pipettor steps down to detect liquid.
 “Liquid Too High for X Pipettor” – error generated when LLS circuitry
detects fluid at a step position that is higher than top of the cup.
 “Liquid Too Low for X Pipettor” – error generated when air is
detected during aspiration.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 5-41
Fluidics Review – Fluidics

Review – Fluidics
Time: 10 mins

1) Which pump is used to create diluted alkaline and acid solutions?

2) Complete the table below by describing the function of each


component.

Component Description or Function


Water Bath Fill
Pump

Internal Probe
Wash Pump

#12 syringe

3) List the 3 areas the degasser provides degassed water.

4) The magnetic pump in the WMU runs continuously. True or False


(Circle one)

5-42 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Optics

6 Optics

Estimated Time: 3 Hours

Objectives

 Identify the physical location and function of optics system


components

 Perform key Remove & Replace, verification, procedures for optics


systems

 Use service tools and diagnostic tools to interpret data and isolate
root causes of optic control system failures

Module Topics

 Optics System Overview

 Optics System Components

 Optics Photometric Sample Processing

 Optics activities

 Summary - Optics

 Review Optics

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-1
Optics Optics System Overview

Optics System Overview


Time: 10 mins Participants should be in front of analyzer for this portion of training.

 Reference: See Alinity c Service Documentation > Instrument


Overview > Optics

The optical system is a reaction cuvette direct photometry system.

 Directs and aligns the light from the source lamp, through the water
bath and cuvette, and then into the optics assembly
 The Alinity c is capable of taking monochromatic (single
wavelength) and bi-chromatic (dual wavelength) measurements
at 16 different wavelengths.

6-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Optics System Components Optics

Optics System Components


Time: 30 mins

Optics Housing

Component Description

1. Lamp and  Provides photometric measurement light source


housing  Requires 11.45VDC (rated at 12V, 20W) from PS4
 Lamp voltage check should be performed at terminal block
at the lamp
 Lamp is always ON when instrument is ON
 Life expectancy rated at 90 days of use, 2000 hours
 Lamp is customer replaceable
 Must be ordered from Abbott

2. Heat Glass  Protects the convex lens from heat distortion


 Replaceable and can be cleaned
 Filter has no specific orientation when replaced

 With use or age, the lamp heat may cause faint brown
spots that may impact some assay reads and cuvette
integrity issues

3. Convex Lens  Focuses the light from a tungsten halogen lamp and passes the
(2) light through the cuvette to measure absorbance changes as
the reaction progresses
 A second convex lens focuses the light through the entrance slit
onto the diffraction grating

4. Water Bath  Separates and seals lamp and optics assembly from water bath
Lens  Replaceable

 Note: Clean with lens paper and Detergent A

5. Cuvette  Cuvettes are checked for integrity prior to sample testing


& Cuvette  Cuvettes are sealed into the segment and replaced as a unit
Segment

 Note: Function previously discussed in Robotics module.

6. Entrance Slit  Rectangular aperture through which light beam passes

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-3
Optics Optics System Components

Component Description

7. Diffraction  Breaks the light beam into 16 wavelengths and reflects the light
Grating onto a photo-diode array

8. Linear  Detects and measures changes in light intensity


Photodiode  Sends signal to the optics pre-amp board
Array

9. Optics Pre-  Converts optical signal to a voltage (0-5V), amplifies signal, and
Amp Board sends to DAQ board

10. Data  Receives photometric data from the optics preamp board,
acquisition quantifies and converts optical signals to a digital format then
(DAQ) board sends data to the CPU

 Note: Boards were reviewed previously.

11. Central  Receives DAQ photometric data and sends it directly to the UIC
processing
unit (CPU)  Note: Boards were reviewed previously.
board

12. SCM UI  Performs the data reduction and result calculation


Computer

Items not show in drawing

Cuvette Wipers  Remove debris and bubbles from cuvettes prior to optical reads
 Replaceable

Optical Trigger  Monitors positional flags on cuvette segments and signals DAQ
Sensor board when cuvette is positioned in front of the Optics for a
read
 Sensor is replaceable; mounting bracket MUST be reused- NOT
replaceable
 Resets Optics wavelength gains and cuvette read offset values
during RUNNING status

6-4 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Optics Photometric Sample Processing Optics

Optics Photometric Sample Processing


Time: 30 mins

The following describes the optic processes utilized during an assay run
and the components involved.

Beginning of a run: Assemblies home

 System briefly pauses to perform checks:


 Gains are checked for each wavelength and the DAQ board
adjusts the lamp for light intensity
 Reads taken through washed cuvettes
 As lamp ages the intensity decreases and the gain increase
 Background, dark voltage reads
 Performed by light shining on spoke in cuvette segment to
block light from entering optics assembly
 Checks for stray light and electrical noise
 Parameter used in final result calculation

 Note: When reaction carousel is homed and in the 4.5 second lock
step wait, the cuvette spoke blocks the light path.

 Trigger check and cuvette read offset calculation


 Detection of cuvette positional flag or tab trailing edge
 Optics determination of cuvette edge (timing and position)

 Cuvette integrity check is performed on each cuvette with


degassed water in cuvette

 Note: Nozzle 6 dispenses the degassed water for the cuvette blank
reading.

 Reads serve as blank readings in final result calculation once it


passes specification
 Failed cuvette integrity readings generate an error code and
lists the cuvette number

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-5
Optics Optics Photometric Sample Processing

Lamp Monitoring

 Monitors the lamp energy to detect lamp output fluctuations and


generates an error while the system is in a run mode. This minimizes
generation of aberrant results caused by normal lamp degradation
 The lamp intensity read is a bi-chromatic calculation of the
absorbance at 340 nm and 380 nm wavelengths
 The readings are analyzed against recent lamp data
 A range (max-min) of the bi-chromatic reads is calculated and
compared to the predefined threshold in the system software
parameters
 Optics errors 4403 and 4404 are generated when the reads are
outside of specifications due to lamp instability and/or an issue with
debris/bubbles in the water bath and/or cuvettes
 4403 (optics system warning, fluctuation detected
 4404 (optics system failure, fluctuation detected)

6-6 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Optics Photometric Sample Processing Optics

During a Sample Run

 Reaction carousel rotates counter clockwise to position the


cuvettes for photometry and other processing functions

 As the cuvettes pass between the light source and the optics
assembly, the trigger sensor signals the DAQ board that a cuvette is
in the light path and in position for an optical reading

 Light passes through the cuvette onto the diffraction grating in the
optics assembly:
 Diffraction grating breaks the beam into 16 wavelengths and
reflects the light onto a photo diode array
 Photo diode array detects and measures changes in the light
intensity
 Photo diode array signal is sent to the preamp board where it is
converted to a voltage and amplified
 Preamp board sends the signal to the DAQ board in the master
card cage

 In the master card cage:


 DAQ board gain control circuitry optimizes the signal and sends
it to the CPU board
 CPU sends the optimized signal to the UIC where the results
are compared to stored calibration data and final result
calculations are performed

After Sample Processing (Water Blank)

 The cuvette washer removes the reaction mixture to waste, and


cleans the cuvette with alkaline wash, acid wash, and DI water

 The cuvette washer dispenses DI water into the cuvette for the
water blank measurement

 The cuvette washer aspirates the water and dries the cuvette in
preparation for the next sample

 If additional sample analysis is not requested, the R1 probe will


dispense water into the cuvette for hydration

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-7
Optics Optics Activities

Optics Activities

Activity: Optics Procedures

Time: 60 mins

Purpose: To gain competency in performing Optics procedures used


in maintenance and troubleshooting.

Materials Needed:
 Standard tool kit
 Beam Height Alignment Tool

Service Tools:
 The Beam height alignment is typically only done on installation or
after replacing identified components.
 Handle lamp with gloved hands.
 Cuvettes are only replaceable as a segment.
 A run must be generated to obtain cuvette integrity results. The
cuvette integrity results are readings obtained from the last time
the cuvette blank was performed.

Action: Perform the following key procedures:

 M&D 4004 Beam Height Alignment

 M&D 4001 Optics Trigger Sensor Check

 M & D 4003 Optics Total Test

 Reference: See Alinity c Service Documentation > Troubleshooting


and Diagnostics > Procedures > Maintenance and Diagnostics List.

1. If instrument is stopped and there are contaminated cuvettes


in reaction carousel, what procedure would be required before
performing sample run? ____________________________________

_________________________________________________________________

6-8 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Optics Activities Optics

2. If all of your wavelengths have a gain value of 4.0, what are


possible failures and causes? ______________________________

_________________________________________________________________

Discussion: Instructor will assist and clarify activity and information


where necessary. Review results and answers after the activity is
completed.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-9
Optics Optics Activities

Activity: Optics Service Scenario and AST Tools

Time: 15 mins

Purpose: To gain competency in Optics-related troubleshooting and


using AST Tools.

Action: Read the scenario and answer the questions below

The lab supervisor at Alpha-Omega Reference Labs calls the Support


Center for samples intermittently going to Exceptions for the past five
days due to “4403 Optics System Warning, Fluctuation Detected.“
The customer has completed the following troubleshooting with the
Support Center:
 Replaced lamp and checked cables
 Replaced and calibrated both reagent probes
 Replaced dryer tip
 Performed the following procedures:
 M&D 5003 Clean Cuvettes Manually
 M&D 5501 Daily Maintenance

1. What checks, measurements, procedures, etc., would you use to


help isolate the cause of the failure? _____________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

6-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Optics Activities Optics

2. What is the difference between an ISA and TSB?

_________________________________________________________________

_________________________________________________________________

3. Name two compliance requirements for documentation of a TSB?

_________________________________________________________________

_________________________________________________________________

Discussion: Check for understanding, clarify questions, and assist with


AST tool use.

Activity: TCT Coding

Time: 10 mins

Purpose: To be familiar with coding ticket appropriately into system

Action: Refer to the Ticket Code Tool to find the best Work Done Code
to represent if the Degasser was replaced to resolve bubbles error.

Write the codes below for the outcome above:


a. Work Done Code” ______________________________________

b. Action Taken Code: _____________________________

c. Reason for Action Code: ________________________

Discussion: Check for understanding, clarify questions, and assist with


AST tool use.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-11
Optics Optics Hardware Summary

Optics Hardware Summary


Time: 10 mins

Hardware Symptoms/Errors Procedures/References

Cuvettes, Cuvette  Assay imprecision  M&D 5910 Wash Cuvettes


Segments  Cuvette integrity errors  M&D 5003 Clean Cuvette
 Optics fluctuations (Error Manually
codes 4403 and/ or 4404)  Observe cuvettes and
 Cuvette tab not detected segments for damaged

 Damaged cuvette wipers

Lamp, Optics  Assay imprecision  Assay precision run


 Optics intensity errors  Verify lamp voltage
 Optics fluctuations (Error  M&D 4003 Optics Total Test
codes 4403 and/ or 4404) and ICT Data
 Cuvette integrity error  M&D 4005 Cuvette
 Low 11.5VDC error Integrity Check
 Observe lamp and cover
are correctly seated
 Replace optics heat glass

Trigger Sensor  Trigger check error  M&D 4001 Optics Trigger


 Cuvette integrity error Sensor Check

 Cuvette tab not detected  M&D 4003 Optics Total Test


and ICT Data
 Check Cuvette Washer
(Nozzle 6)

6-12 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Review – Optics Optics

Review – Optics
Time: 10 mins

1) What is the purpose of the Trigger sensor?

2) Lamp Monitoring occurs through blank read. True or False (Circle


one)

3) Which optical components are replaceable?


a) Optics lamp
b) Photodiode Array
c) Optics Pre-Amp Board
d) Cuvette segment

4) What is the power source for the Lamp voltage?

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 6-13
Temperature Control

7 Temperature Control

Estimated Time: 2 Hours

Objectives

 Identify the physical location and function of components


associated with temperature control

 Perform key Remove & Replace and verification procedures for


temperature control components

 Use service tools and diagnostic tools to interpret data and isolate
root causes of temperature control system failures

Module Topics

 Temperature Control Overview

 Water Bath temperature control system components

 Reagent supply center cooler unit

 Temperature Control Activities

 Summary – Temperature Troubleshooting

 Review – Temperature Systems

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 7-1
Temperature Control Temperature Control Overview

Temperature Control Overview


Time: 15 mins

Delivery Method: Review the following system component descriptions


at the instrument.

 Reference: See KM Article ID: K28516451 Alinity c Service


Documentation > Instrument Overview > Temperature Control and
Temperature Diagrams.

Temperature Control

Temperature control is the ability to both monitor a temperature and


provide feedback to adjust that temperature in order to maintain
a desired set point. Signals are sent to initiate heating or cooling,
depending on the system.

Temperature controlled areas include:


 Water Bath (heater)
 Reagent Supply Center (self-contained internal process)

Temperature Monitoring

Temperature monitoring involves reading a temperature for reporting


purposes without the means to adjust that temperature. Temperature
signals are converted to a readable format for display to the user.

Temperature monitored areas include:


 Ambient temperature
 Reagent carousel lid heaters

7-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Temperature Control Overview Temperature Control

The following are areas where temperature is monitored and/or


controlled for recovery within a specified range.

SM AC/DC
Actual
Area Thermistor Controller
Temp Range Temperature
Monitored Location Displayed Temp
Adjustment
Adjustment
Reagent 2–10°C Bottom of N/A N/A
Supply Reagent
Center Carousel area
Water Bath 36.8–37.2°C Bottom of Water VR2 TBC Bd
(see Note below) Bath
Ambient 15–30°C WMU VR1 N/A

 Note: Field service adjustment is to 36.9-37.1°C.

 Note: Ambient temperature is related to the lab surrounding


environment

Component Function
Ambient  Located in the WMU area to monitor internal instrument temperature
Thermistor  Temperature specification 15°–30°C
 Control: SM AC/DC Controller; VR1 adjustment potentiometer adjusts
display temperature only
 Replaceable

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 7-3
Temperature Control Water Bath Temperature Control System Components

Water Bath Temperature Control System


Components
Time: 20 mins

The water bath heater and circulation pump are responsible for
circulating heated water (37°C) to the water bath and ICT module
holder/jacket.

Water temperature is monitored with the Water Bath Temperature


Sensor located in the bottom of the Water Bath.

Water Bath Temperature Control System Components

Component Function
Heater  Located in the Water Management Unit
 Heats degassed DI water supplied to the Water Bath to 37°C ±0.2°C
 Controlled from Thermal Bath Controller (TBC) board, located in the
driver box
 Voltage ramps up and down as heat to maintain bath
temperature
 Water bath heater is turned OFF any time the float switch detects
a low water level condition
 Replaceable
Water Bath  Located at bottom of Water Bath to monitor bath temperatures
Control  Temperature specification: 37°C ±0.2°C
Thermistor
 Temperatures outside 36.8°–37.2°C signals SM AC/DC Controller
Board to generate errors
 Temperature reported to the SM AC/DC Controller; VR2 adjustment
potentiometer adjusts display temperature only
 Replaceable
RD20 Pump  Located in WMU and provides water circulation
(Water bath  Is ON constantly when the water bath float switch indicates full
circulation
pump)  24VDC power from TBC board
 Control: SM AC/DC controller board
 Replaceable

7-4 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Water Bath Temperature Control System Components Temperature Control

Component Function
Temperature  Located in the Driver Box
Bath Controller  Controls actual water bath temperature
Board (TBC)
 Provides 24VDC to RD20 circulating pump
 Provides 100VAC to water bath heating element
 Feedback control through thermistor
 Contains circuitry to open and close the 24VAC motor drain valve
used to empty the water bath during M&D procedures
 Contains two LEDs to indicate status of heater
 CPU CMD LED:2
 Displays ON/OFF signal status from CPU
 ON when signal is output and water bath float switch indicates
full
 Heater LED: 1
 ON when heater is activated
 Dims when temperature is constant and temperature control
stabilized
 Contains two switches to adjust the water temperature in the water
bath.

 Note: Water Bath temperature may be influenced by lab


environment; adhering to the instrument site specification is
important.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 7-5
Temperature Control Reagent Supply Center Cooler Unit

Reagent Supply Center Cooler Unit


Time: 20 mins

Component Function
Thermoelectric  Cools reagent supply center assay reagents to 2-10°C
Devices (TEDs)  Control: Cooler Controller Board
(8)
 Power: PS5 and PS8 provide 12VDC for the TEDs
 TEDs are not individually replaceable. Replace entire cooling unit.

 Note: Instrument temperature errors can be caused by TED


component failure or control board.
Circulation  Pump circulates cooling fluid between reagent carousel container
Pump and Cooler Unit
 Control: Cooler Controller Board
 Power: 12VDC provided by PS5 and PS8
 Replaceable
Temperature  Detects Reagent Supply Center air temperature and send signal to
Detector Cooler Controller Board
 Mounted inside the Reagent Supply Center
 Replaceable
Fans (2)  Removes hot air exhaust from TEDs
 Power: 12VDC
Heat Exchange  Coated aluminum plate where liquid antifreeze/coolant is circulated
Block by a pump

7-6 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Reagent Supply Center Cooler Unit Temperature Control

Component Function
Reagent  Contains float sensor and signals sent to Cooler Controller Board
Coolant Bottle  Coolant is Abbott customized ethylene glycol solution added during
installation, topped off annually, or as needed

 Note: Coolant formulated for Abbott, must be purchased from


Abbott.

Reagent  Cover heaters are placed around the two reagent aspiration holes
Carousel Lid  Prevents condensation from forming around the opening
Heaters (2)
 Minimize probe/reagent contamination due to condensation drips
 Monitored by Cooler Controller Board
 Replaceable

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 7-7
Temperature Control Reagent Supply Center Cooler Unit

Temperature Control Activities

Activity: Water Bath Temperature Control

Time: 30 mins

Purpose: To familiarize participants with water bath service procedures.

Materials Needed:
 Standard Tool Kit
 Calibrated thermometer (range + 0.01 degrees)

Service Tips:
 Displayed Water Bath and Ambient temperatures are adjustable
on the SM AC/DC Controller.
 Water in the bath is circulated when the float switch indicates full.

Actions: Perform the following diagnostic procedures:


 M&D 4301 Temperature Status
 P-4017 Water Bath Temperature Detector Adjustment
 P-4018 Water Bath Heater Adjustment

1. If the water bath temperature in the maintenance menu was


displaying 37.5°C, what corrective actions, if any, would you
perform?

____________________________________________________________

2. If the water bath temperature in the maintenance menu was


displaying 35.0°C, and the instrument was displaying a water
bath temperature error, what corrective action, if any, would you
perform?

____________________________________________________________
 Discussion: Check understanding and clarify key points.

7-8 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Reagent Supply Center Cooler Unit Temperature Control

Activity: Cooler Unit

Time: 15 mins

Purpose: To practice installation, PM, and diagnostic procedures to


evaluate the Cooler Unit.

Materials needed:
 Coolant for demonstration
 Coolant kit (tubing & funnel) for demonstration

Service Tips:
 Use only the specific Cooler Unit Coolant to prevent errors and
component damage.
 Coolant is formulated for Abbott and must be obtained from
Abbott.
 The Cooler coolant fluid line should be free from bubbles.
 The Reagent Supply temperature is NOT adjustable
 Coolant line MUST be free of air bubbles

Actions: Only review the following procedures:


 P-4053 Coolant Fill
 P-4052 Coolant Refill

1. When would you add Cooler Unit coolant?

________________________________________________________________

________________________________________________________________

2. What is the Part Number for the Cooler Unit Coolant?

________________________________________________________________

3. List high cost parts for the cooling system.

________________________________________________________________

Discussion: Check for understanding and clarify key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 7-9
Temperature Control Temperature – Hardware Summary

Temperature – Hardware Summary


Time: 10 mins

Hardware Symptoms/Errors Procedures/References


Water Bath Heater  Water bath temperature  Cycle system power
high/low errors  Observe operation
 Water bath float switch dirty,  Look for water circulation
mis-seated, or failed
 M&D 4301 Temperature Status
 Instrument not leveled
 P-4018 Water Bath Heater
 Failed heater assembly or Adjustment
component
 M&D 4802 Robotics Test Tool >
 Mis-adjusted temperature Water Bath drain/fill
bath controller board
Reagent Supply  Reagent supply center  M&D 4301 Temperature Status
Center Cooler Unit temperature high  Observe operation
 Verify drain tubing is not kinked
or obstructed
 P-4052 Coolant Refill
 P-4053 Coolant Fill

7-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Review - Temperature Control Temperature Control

Review - Temperature Control


Time: 10 mins

1) Complete the table below

Device Power Source Voltage


Thermoelectric Devices (TEDs)

Water Bath Heater Pump

Water Bath Assembly Heating


Element

2) The water bath heater assembly is responsible for heating


and supplying 37°C water to ____________________
and _______________________.

3) What components are replaceable on the cooling unit?

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 7-11
Installation and Integration

8 Installation and Integration

Estimated Time: 2 Hours

Objectives

 Review and perform planned maintenance (PM) and Total Call


procedures

 Review procedures to install the c system

 Review current list of instrument-related ISAs & TSBs

 Locate and review Alinity ci-series multimodule installation and


integration process

 Identify Alinity ci-series multimodule components location and


function

 Perform activities associated with the Alinity ci-series multimodule


installation and integration

Module Topics

 Installation

 Installation Activities: Installation PVT

 Multimodule Integration Installation Activity : Review of integration


installation

 Preventive Maintenance and Total Call

 Preventive Maintenance and Total Call Activities

 Review

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 8-1
Installation and Integration

Installation
Time: 5 mins

Delivery Method: Review the following points in class and at the


instrument as needed.

Installation Documentation

Review the following key installation documents and discuss the


related pre-site activities.

 Reference: See Alinity c Service Documentation > Installation,


Removal and Relocation Documents, and c-series/SCM ISAs and
TSBs

 Pre-site inspection
 Pre-site installation checklist

Discuss the installation procedures and checklist items relevant to a


standalone c-series configuration.
 SCM and UIC software*
 Alinity c processing module (single module configuration)
 Multimodule and integrated system key points
 Review ISA and TSB

8-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Installation Activities Installation and Integration

Installation Activities

Activity: Installation PVT

Time: 40 mins

Purpose: To familiarize service personnel with installation PVT procedure


required during a new instrument install.

Actions: Perform the following actions and steps included ISA 210-001
Alinity c Installation Procedure; Operation Qualification- Performance
Verification Testing (PVT) for the following activity.

 Note: Toshiba manufacturing requires all new systems to pass the


PVT acceptance criteria prior to shipping. Performing the PVT
during new system installation verifies that issues have not occurred
as a result of shipping and/or the installation process.

 Reference: See ISA 210-001/E Alinity c Installation


Procedure,Operation Qualification- Performance Verification
Testing (PVT)

Verify calibration status of AST, ALKP, TP and ICT assays. Calibrate as


required.
 Perform a manual backup (See online operations manual)
 Create a patient order for AST, ALKP, and K and run them as many
times as the instructor specifies
 Load control levels as specified by instructor and place them into
the separate racks
 Load racks into RSM and start the run
 Print results
 Record and evaluate results in the table below

Difference
Assay High Low (High - Pass/Fail
Low)

AST

ALKP

TP

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 8-3
Installation and Integration Multimodule Integration Installation Activity

Difference
Assay High Low (High - Pass/Fail
Low)

Na

CI

 Did assays meet acceptance criteria? Yes / No (Circle one)

Discussion: Instructor will check for understanding by observing the


activity and clarifying key points.

Multimodule Integration Installation


Activity
Time: 45 mins
Instructor-led Activity: Review of Integration Installation

 Video: Training videos are intended for class instruction only and
SHOULD NOT BE DISTRIBUTED.

Time: 35 minsPurpose: To be familiar with the Alinity multimodule ci-


series installation integration process.

Actions: Open the following procedures listed below and follow along
during the video review:
 Alinity c-series Module Installation procedure
 Alinity i-series Module Installation procedure
 Alinity ci-series multimodule installation and integration
procedure

 Reference: Alinity c-series Installation service procedure

8-4 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Multimodule Integration Installation Activity Installation and Integration

Action: Review related Alinity multimodule installation integration key


points.
 Service Tips:
 Transport Belt tension is set when Transport motor belt
adjustment mechanism screw is loosened.
 The bottom slot on the Transport Clamp holds the belt end
from the c-series end and the top slot holds the belt end
from the i-series module.
 SuperLube Oil is used only on the left and right Idler Pulley
shoulders to keep the belt inside the pulley.
 The instrument leveling feet are only secured tight to the
floor after the Alinity ci-series modules are integrated.

 Review the following components and locations at the instrument:


 Alinity c-series Module
 Bubble level placement
 12Amp circuit breaker on Power Supply
 Chain Rail
 Left and right belt pulleys and lubrication points
 Alinity ci-series SCM Module
 Transport Motor Adjustment Belt Mechanism and screw the
SCM Module Control Power Switch
 Articulated Arm lift adjustment screw

 Note: The adjustment screw is visible when the monitor is pushed


down and the articulated arm is in the upper most position. This will
usually require use of an elevated view.

 Alinity i-series Module


 Stand-alone cables for the Load/ Unload Board path of
the 3 cables to the SCM from the Load/ Unload Board and
Process Module Controller
 Chain Rail
 Left and right belt pulleys and lubrication points

Discussion: Involve participants during the component review activity


and clarify key points.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 8-5
Installation and Integration Prognostic Health Management and Preventive Maintenance

Prognostic Health Management and


Preventive Maintenance
Time: 10 mins

Prognostics focuses on predicting the time at which a system or a


component will no longer perform its intended function.

Prognostic Health Notification (PHN) alerts are generated and sent to


service when a single unique algorithm trend identifies a component is
no longer functions as designed or intended function.

 Note: Related procedures were practiced throughout class to learn


the system. This section is only a summary review.

 Reference: See Alinity c Service Documentation > Preventive


Maintenance > current ISA’s

 Review Prognostic Health Management (PHM)

 Use ISAs to review updated procedures:


 Special tools and materials
 PHN Alerts Summary ISA
 Procedures performed during the PM vs. PHN alerts
 Benefits of PHM

8-6 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Prognostic Health Management and Preventive Maintenance Installation and Integration

[This Page Intentionally Left Blank]

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 8-7
Installation and Integration Prognostic Health Management & Preventive Maintenance Activities

Prognostic Health Management &


Preventive Maintenance Activities

Activity: Proactive Maintenance

Purpose: To practice ticket coding associated with proactive activities.


Time: 10 mins
Actions: Complete the following ticket coding exercise.

1. After completing PM activities on the c-series instrument, find the


Work Done Code to document the ticket.

Work Done Code: _______________________________

2. Identify the Work Done Code used to document the completion of


the c-series Instrument Total Call procedure.

Work Done Code: _______________________________

Discussion: Instructor will check for understanding by observing the


responses and clarifying key points.

Activity: AST Tools

Time: 10 mins Purpose: To be proficient in service skills associated with AST tools,PM
and related procedures.

Action: Using the History and Maintenance Log saved earlier in the
week, load and view log in LOG-ICAL and then answer the following:

1. Is scheduled daily maintenance up to date? Yes / No (Circle one)

2. Did all performed maintenance procedures pass?


Yes / No (Circle one.)

3. How is a failed maintenance procedure displayed?

________________________________________________________________

4. What error has the highest occurrence in the History log?

________________________________________________________________

5. How could you utilize these logs prior to going on site to perform a
PM?

________________________________________________________________

8-8 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Prognostic Health Management & Preventive Maintenance Activities Installation and Integration

6. Choose the best AST Tool to use and review the overall instrument
and account health Real Time for ASE Proactive Customer Care. Be
prepared to explain your answer. (Choose one)
a. AbbottLink
a. ONeview [*]
a. LOG-ICAL
a. HCI GSR report
 Answer:

Discussion: Instructor will review information, assist where needed and


clarify key points

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 8-9
Installation and Integration Prognostic Health Management & Preventive Maintenance Activities

Review
Time: 5 mins 1) What are the required conditions for PHN Alerts?

a. An instrument must have an AbbottLink connection for PHN


alerts.

b. An instrument must have an AlinIQ Always On service contract


for PHN alerts.

2) What is the Alinity c PM interval?

3) Are special tools or parts required to complete the PM? Yes / No


(circle one)

8-10 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Lab Practical and Final Exam

9 Lab Practical and Final Exam

Estimated Time: 5 Hours

Objectives

 Demonstrate knowledge, competencies and skills applicable


to c-series system field service through written and practical
assessments

Module Topics

 Overview of Lab Practical and Final Exam

 Lab Practical and Final Exam

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 9-1
Lab Practical and Final Exam Overview of Lab Practical and Final Exam

Overview of Lab Practical and Final Exam


Participant will perform the following independent activities at
the instrument using available service tools. Participants will need
to successfully and independently complete both for instrument
certification.

 Perform troubleshooting based on the direction of the certified


instrument trainer

 Complete exam in LMS using service tools

 Note: Instructor will observe use of tools and resources and provide
participant feedback, as needed.

Lab Practical and Final Exam

Activity: Final Exam

Time: 60 mins

Final Assessment: Participants will access current learning


management system (LMS) and complete the Exit Exam and Course
Survey

 Note: Participants are to complete the knowledge assessment


exam while waiting to complete the troubleshooting hands-on
portion of the exam.

9-2 Alinity c Global Field Service Training | Internal Use Only | 80001189-101
Overview of Lab Practical and Final Exam Lab Practical and Final Exam

Lab Practical and Final Exam

Activity: Troubleshooting Practical

Time: 240 mins

Purpose: The lab practical troubleshooting activity is designed for


participants to demonstrate their knowledge and understanding of the
instrument, service processes, documents, and tools to begin to service
the instrument effectively.

 Note: To pass this portion of the class, participants are required to


demonstrate independently the following basic practices:

Key Notes

 Use service documentation (KM, Service and Support resources,


diagrams, assay inserts, instrument software reports, error codes,
and data, etc.) and tools (test equipment, alignment tools, etc.)
appropriately

 Identify and evaluate normal vs abnormal system conditions

 Locate system components and use proper terminology

 Resolve basic error situations independently, with minimal instructor


guidance

 Use effective or logical troubleshooting methods to resolve


unknown error conditions

 Demonstrate basic customer interaction (ASE) skills

Actions: Begin processing a QC Run or setup based on instructor


guidance.

1. If an error is detected or an error state occurs, STOP.

2. Use troubleshooting reference documentation as indicated in Key


Notes above.

3. Observe, make comparisons, perform procedures, gather data/


information etc., for use in isolating the failure. Use the STEP process
to help identify and resolve the error condition.

4. Perform the repair and required verification procedures to return


the instrument to a Ready status based on instructor guidance.

Discussion: Be prepared to share your troubleshooting process with


the instructor, including how you arrived at the solution. Instructor will
provide class assessment and recommendations post completion.

Alinity c Global Field Service Training | Internal Use Only | 80001189-101 9-3
Appendix - Additional Handouts and Information

Appendix - Additional
A Handouts and Information

Alinity c-series Field Service Training | Global Service Training | 80001189-101 A-1
Appendix - Additional Handouts and Information

Basic Operations Flowchart

 Note: The steps above were created for Alinity ci-series Software
version 1.0. Operations steps may vary depending on software
version used. Please refer to the current Alinity ci-series Operations
Manual for additional detail.

A-2 Alinity c-series Field Service Training | Global Service Training | 80001189-101
Appendix - Additional Handouts and Information

Alinity c Power Distribution

Alinity c-series Field Service Training | Global Service Training | 80001189-101 A-3
Appendix - Additional Handouts and Information

Water Management Unit (WMU)

Component Illustration
1. Water Bath Filter
2. Low Concentration Waste Tank
3. Inlet Water Valve and Flow
Restrictor
4. DI Water and External Waste
Tubing Connectors
5. Water Bath Fill Peristaltic Pump
6. Water Heater
7. Water Bath Drain Valve
8. External Probe/Mixer/Cuvette
Wash RD30 24 VDC Water Pump
9. Internal Probe Wash 24 VDC
Water Pump with Damper
10. Water Bath Circulation RD20 24
VDC Water Pump
11. DI Water Tank
12. Connector Panel
13. Float Sensors

A-4 Alinity c-series Field Service Training | Global Service Training | 80001189-101
Appendix - Additional Handouts and Information

Alinity c Cuvette Washer Nozzles

 During the Cuvette wash process: dispense & aspiration occurs


simultaneously
-Exception, degassed water is dispensed by Nozzle 6 to create a
blank then aspirated by Nozzle 7
- vacuum aspirations will remove all fluid in the Cuvettes prior to the
reaction carousel rotation

ng

Alinity c-series Field Service Training | Global Service Training | 80001189-101 A-5

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